Data / Medical devices / Canada / BTNX Inc.
BTNX Inc.: FDA-registered device maker in Pickering Ontario, Canada, 56 510(k) clearances
BTNX Inc. is registered with the FDA (registration 3003917514) in Pickering Ontario, Canada. It lists 77 device types. The FDA files 56 510(k) clearances under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003917514
- Address
- 722 Rosebank Road, Pickering Ontario, Canada, L1W 4B2
- Owner or operator
- BTNX Inc. (9058575)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Repackager or relabeler
- First device listed
- February 4, 2005
- Registered through
- 2026
- Brand names listed
- BTNX Inc. Rapid Response A1c System, BTNX Inc. Rapid Response Drugs of Abuse Test (Urine), BTNX Inc. Rapid Response Drugs of Abuse Test Cup, BTNX Inc. Rapid Response Drugs of Abuse Test Panel, BTNX Inc. Rapid Response Gluco-MD Blood Glucose Monitoring System, BTNX Inc. Rapid Response LH Ovulation Test Cassette (Urine), BTNX Inc. Rapid Response Midstream Pregnancy Test OTC (Urine) (Midstream), BTNX Inc. Rapid Response U500 Urine Analyzer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Foreign private label distributor | accessdata.fda.gov |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Automated Urinalysis System | KQO | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Blood, Occult, Colorimetric, In Urine | JIO | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Electrolyte Controls (Assayed And Unassayed) | JJR | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzymatic Method, Creatinine | JFY | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Barbiturate | DIS | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Benzodiazepine | JXM | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Methadone | DJR | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Phencyclidine | LCM | U | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Propoxyphene | JXN | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Rotavirus | LIQ | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Foreign private label distributor | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Refractometer For Clinical Use | JRE | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Infectious Mononucleosis | KTN | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test System, Nicotine, Cotinine, Metabolites | MRS | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Amphetamine, Over The Counter | NFT | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Barbiturate, Over The Counter | PTH | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Benzodiazepine, Over The Counter | NFV | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Cannabinoid, Over The Counter | NFW | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Methadone, Over The Counter | PTG | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Methamphetamine, Over The Counter | NGG | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Morphine, Over The Counter | NGI | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | NGJ | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Opiates, Over The Counter | NGL | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | U | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | PVI | 2 | Foreign private label distributor | accessdata.fda.gov |
| Test, Propoxyphene, Over The Counter | QBF | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Thin Layer Chromatography, Methamphetamine | DJC | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Thin Layer Chromatography, Morphine | DNK | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Urinalysis Controls (Assayed And Unassayed) | JJW | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2025 | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | NFT | Substantially Equivalent | Assure Tech., LLC | accessdata.fda.gov |
| February 27, 2025 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| October 7, 2024 | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | SCA | Unknown | Healgen | accessdata.fda.gov |
| September 27, 2024 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| August 13, 2024 | K241978 | Shinetell Digital Pregnancy Test | LCX | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| November 2, 2023 | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| October 26, 2023 | K233417 | AllTest Fentanyl Urine Test Cassette | NGL | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| July 31, 2023 | K231698 | AllTest Fentanyl Rapid Test (Urine) | DJG | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| March 17, 2023 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | LDJ | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| November 10, 2022 | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| March 16, 2022 | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | GTY | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| December 2, 2019 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | FMK | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| March 27, 2019 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | DKZ | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| August 20, 2018 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | NFT | Substantially Equivalent | Assure Tech. (Hangzhou) Co, Ltd. | accessdata.fda.gov |
| April 5, 2018 | K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | NFT | Substantially Equivalent | Assure Tech. (Hangzhou) Co, Ltd. | accessdata.fda.gov |
| August 2, 2017 | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| July 6, 2016 | K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | DJC | Substantially Equivalent | Assure Tech. (Hangzhou) Co, Ltd. | accessdata.fda.gov |
| May 23, 2016 | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| February 24, 2016 | K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | JHI | Substantially Equivalent | Assure Tech. Co., Ltd. | accessdata.fda.gov |
| January 29, 2016 | K142664 | URight Hemoglobin A1c system, FORA A1c System | LCP | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| April 30, 2015 | K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | JIR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 9, 2014 | K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | JHI | Substantially Equivalent | Polymed Therapeutics, Inc. | accessdata.fda.gov |
| May 24, 2013 | K121065 | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE | DKZ | Substantially Equivalent | Polymed Therapeutics, Inc. | accessdata.fda.gov |
| March 14, 2013 | K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | LCX | Substantially Equivalent | Polymed Therapeutics, Inc. | accessdata.fda.gov |
| July 17, 2012 | K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | JHI | Substantially Equivalent | Polymed Therapeutics, Inc. | accessdata.fda.gov |
| March 6, 2012 | K120124 | FORESIGHT U120 URINE ANALYZER | JIL | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 18, 2012 | K111221 | MISSION U500 URINE ANALYZER | JIO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| September 14, 2011 | K110309 | FOB ONE STEP RAPID TEST | KHE | Substantially Equivalent | Orient Gene Biotech | accessdata.fda.gov |
| February 2, 2011 | K103387 | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | JJW | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 28, 2010 | K093143 | MISSION BREATH ALCOHOL DETECTOR | DJZ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 10, 2009 | K092099 | NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| October 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 30, 2007 | K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | KQO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 26, 2007 | K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | JIR | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| November 22, 2006 | K063212 | CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| August 11, 2006 | K061559 | ACON URINALYSIS REAGENT STRIPS | CDM | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| July 14, 2006 | K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | KHE | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| August 16, 2005 | K051526 | URITEK-720+ URINE ANALYZER | KQO | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| August 5, 2005 | K051854 | CLEVER CHEK TD-4225, MODEL TD-4225 | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| February 28, 2005 | K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | KTN | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 22, 2004 | K041441 | SAS INFLUENZA A TEST | PSZ | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| July 22, 2004 | K041439 | SAS INFLUENZA B TEST | PSZ | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| July 25, 2003 | K030912 | THYRO TEST | JLW | Substantially Equivalent | Thryotec | accessdata.fda.gov |
| April 2, 2003 | K024350 | ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE | LYR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 29, 2003 | K022845 | SAS RSV TEST | GQG | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| November 20, 2002 | K021789 | QUICKLAB RSV | GQG | Substantially Equivalent | Integrated Biotechnology Corp. | accessdata.fda.gov |
| October 17, 2002 | K023270 | SAS STREPALERT | GTY | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| May 7, 2001 | K010582 | ACON STREP A RAPID TEST STRIP | GTY | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| August 19, 1999 | K990630 | SAS ADENO TEST | GOD | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| August 9, 1999 | K990842 | SAS ROTA TEST | LIQ | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| April 8, 1997 | K970250 | CLINISTRIP | JIL | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| May 1, 1996 | K960733 | MINISTICK PREGNANCY TEST | LCX | Substantially Equivalent | Vanguard Biomedical Corp. | accessdata.fda.gov |
| March 25, 1993 | K930014 | PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST | JHI | Substantially Equivalent | Vanguard Biomedical Corp. | accessdata.fda.gov |
| October 17, 1991 | K914254 | HOMECLINIC ONE STEP PREGNANCY TEST | LCX | Substantially Equivalent | Vanguard Biomedical Corp. | accessdata.fda.gov |
| October 11, 1991 | K914253 | PROCLINIC ONE STEP PREGNANCY TEST | JHI | Substantially Equivalent | Vanguard Biomedical Corp. | accessdata.fda.gov |
| March 21, 1991 | K910351 | MINICLINIC OVULATION PREDICTION TEST | CEP | Substantially Equivalent | Vanguard Biomedical Corp. | accessdata.fda.gov |
Compare with other makers
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Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.