Data / Medical devices / United States / Germaine Laboratories, Inc.
Germaine Laboratories, Inc.: FDA-registered device maker in San Antonio, TX, United States, 49 510(k) clearances
Germaine Laboratories, Inc. is registered with the FDA (registration 1649661) in San Antonio, TX, United States. It lists 79 device types. The FDA files 49 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1649661
- FEI number
- 3001451797
- Address
- 11030 Wye Drive, San Antonio, TX, United States, 78217
- Owner or operator
- GERMAINE LABORATORIES, INC. (9031523)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 8, 1997
- Registered through
- 2026
- Brand names listed
- AccuHome, AimScreen Fentanyl, AimScreen Xylazine, AimStep, AimStep H. Pylori, AimStrip, AimStrip Fentanyl, AimStrip MACRE and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| January 15, 2026 | K252283 | Nano-Check Influenza A+B Test | PSZ | Substantially Equivalent | Nano-Ditech Corporation | 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 |
| December 17, 2024 | K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | NGL | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| October 7, 2024 | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | SCA | Unknown | Healgen | accessdata.fda.gov |
| October 26, 2023 | K233417 | AllTest Fentanyl Urine Test Cassette | NGL | Substantially Equivalent | Hangzhou AllTest Biotech 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 |
| August 18, 2015 | K151348 | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) | LFG | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| August 13, 2015 | K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| April 30, 2015 | K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | JIR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 31, 2014 | K133343 | WONDFO RAPID STREP A TEST | GTY | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
| August 5, 2013 | K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | GKR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| June 21, 2013 | K130295 | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | NBW | Substantially Equivalent | Infopia Co, Ltd. | accessdata.fda.gov |
| July 3, 2012 | K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | DIF | Substantially Equivalent | Biochemical Diagnostic, 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 |
| 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, 2011 | K102664 | HEMA SCREEN ER | KHE | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| August 6, 2010 | K093879 | MISSION SALIVA ALCOHOL TEST STRIP | DIC | 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 |
| April 8, 2009 | K090057 | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| September 17, 2008 | K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| June 21, 2007 | K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| May 11, 2007 | K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | KHE | Substantially Equivalent | New Bay Bioresearch Co. , Ltd. | accessdata.fda.gov |
| August 11, 2006 | K061559 | ACON URINALYSIS REAGENT STRIPS | CDM | Substantially Equivalent | Acon Laboratories Co. | 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 |
| May 19, 2004 | K040445 | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE | JXN | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 3, 2004 | K040274 | ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| June 10, 2003 | K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | LYR | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| July 17, 2002 | K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | LFG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| January 22, 2002 | K013857 | AIMSTEP PREGNANCY | DHA | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
| November 9, 2001 | K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE | DIS | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 15, 2001 | K012595 | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE | DJR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| September 17, 2001 | K012300 | ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE | JXM | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| August 9, 2001 | K011730 | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE | LCM | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 31, 2001 | K011673 | ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE | DKZ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 31, 2001 | K011672 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 9, 2001 | K010841 | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE | DIO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 7, 2001 | K010582 | ACON STREP A RAPID TEST STRIP | GTY | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| March 15, 2001 | K003557 | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) | LDJ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| November 25, 1998 | K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | GTY | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 16, 1998 | K981165 | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST | JHI | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
| March 6, 1998 | K980531 | AIMSTEP PREGNANCY | JHI | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
| January 2, 1998 | K974512 | AIMSTICK PBD COMBO PREGNANCY | DHA | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
| January 2, 1998 | K974368 | AIMSTICK PBD PREGNANCY | DHA | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
| December 19, 1997 | K973825 | MIDSTREAM HOME REGNANCY TEST | DHA | Substantially Equivalent | Germaine Laboratories, Inc. | accessdata.fda.gov |
| March 10, 1987 | K864731 | OCEAN SCIENTIFIC VDRL TEST | GMQ | Substantially Equivalent | Ocean Scientific, Inc. | accessdata.fda.gov |
| November 24, 1986 | K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS | JJY | Substantially Equivalent | Biodiagnostic Intl | accessdata.fda.gov |
| July 2, 1982 | K821388 | SERO/TEX CRP TEST | DCN | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
| May 21, 1982 | K821319 | SERO/TEX RF TEST | DHR | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
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Updated January 15, 2026. 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.