Data / Medical devices / United States / Stanbio Laboratory
Stanbio Laboratory: FDA-registered device maker in Boerne, TX, United States, 48 510(k) clearances
Stanbio Laboratory is registered with the FDA (registration 1616487) in Boerne, TX, United States. It lists 83 device types. The FDA files 48 510(k) clearances under its listings, the newest dated June 12, 2020. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1616487
- Address
- 1261 North Main ST., Boerne, TX, United States, 78006
- Owner or operator
- STANBIO LABORATORY (1616487)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 15, 1977
- Registered through
- 2026
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 |
|---|---|---|---|---|---|---|
| June 12, 2020 | K200909 | Hemo Control (optional Add Pack Hemo Control DM) | GKR | Substantially Equivalent | Ekf-Diagnostic GmbH | accessdata.fda.gov |
| April 6, 2018 | K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | GKR | Substantially Equivalent | Ekf-Diagnostic GmbH | accessdata.fda.gov |
| April 18, 2017 | K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set | PTF | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| November 10, 2016 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| March 6, 2012 | K120124 | FORESIGHT U120 URINE ANALYZER | JIL | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 17, 2011 | K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | LCP | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| June 10, 2009 | K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| July 18, 2008 | K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| July 30, 2007 | K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | KQO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| August 11, 2006 | K061559 | ACON URINALYSIS REAGENT STRIPS | CDM | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| June 30, 2005 | K050283 | CREATININE LIQUICOLOR | JFY | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| June 30, 2005 | K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | JFM | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| May 9, 2005 | K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | KQO | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| March 14, 2005 | K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | Stanbio Laboratory | 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 |
| February 15, 2005 | K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | JJE | Substantially Equivalent | Tokyo Boeki Medical System , Ltd. | accessdata.fda.gov |
| December 27, 2004 | K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 | KHS | Substantially Equivalent | Diagnostic Chemicals , Ltd. | accessdata.fda.gov |
| October 24, 2003 | K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| August 6, 2003 | K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | Substantially Equivalent | Pointe Scientific, Inc., | 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 |
| June 21, 2002 | K020378 | QUPID PLUS E.R. | JHI | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| February 11, 2002 | K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | KHG | Substantially Equivalent | Gds Technology | accessdata.fda.gov |
| May 7, 2001 | K010582 | ACON STREP A RAPID TEST STRIP | GTY | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| February 18, 1998 | K974429 | RAPET CRP | DCN | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| February 17, 1998 | K974370 | RAPET RF | DHR | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| July 17, 1997 | K972155 | CREATINE KINASE (CK) | CGS | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| December 26, 1996 | K962418 | UREA NITROGEN (BUN) LIQUI-UV | CDQ | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| September 25, 1995 | K952385 | HEMA-TROL Q-CHECK | JJY | Substantially Equivalent | Medical Specialties Intl., Inc. | accessdata.fda.gov |
| November 21, 1994 | K942958 | CREATINE KINASE MB DETERMINATION (UV) | JHW | Substantially Equivalent | Biochemical Trade, Inc. | accessdata.fda.gov |
| May 17, 1994 | K941313 | STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET | CJE | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| December 2, 1993 | K934701 | REAGENTS FOR COBAS ISE MODULE | JIX | Substantially Equivalent | Alko Diagnostic Corp. | accessdata.fda.gov |
| November 2, 1992 | K924248 | ACCUTEX SLE LATEX TEST | LJM | Substantially Equivalent | J.S. Medical Assoc. | accessdata.fda.gov |
| May 13, 1992 | K921625 | CALCIUM-ARSENAZO III REAGENT SET | CIC | Substantially Equivalent | Pointe Scientific, Inc., | accessdata.fda.gov |
| July 3, 1991 | K911075 | COLOSCREEN | KHE | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| March 4, 1991 | K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | JIN | Substantially Equivalent | Gds Diagnostics | accessdata.fda.gov |
| January 31, 1991 | K905651 | KINETIC AMYLASE DETERMINATION | JFJ | Substantially Equivalent | Biochemical Trade, Inc. | accessdata.fda.gov |
| February 7, 1989 | K883170 | STANBIO MAGNESIUM TEST SET, CAT. NO 0130 | JGJ | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| September 9, 1988 | K882938 | STAT FAX(TM) | JJQ | Substantially Equivalent | Awareness Technology, Inc. | accessdata.fda.gov |
| June 10, 1988 | K880576 | RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) | CJY | Substantially Equivalent | Reagents Applications, Inc. | accessdata.fda.gov |
| May 23, 1988 | K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | GMQ | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| April 29, 1987 | K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT | CFR | Substantially Equivalent | Biochemical Trade, Inc. | accessdata.fda.gov |
| August 8, 1986 | K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | LCP | Substantially Equivalent | Sandare Chemical Co., Inc. | accessdata.fda.gov |
| August 16, 1983 | K832159 | UNITIZED ENZYMATIC GLUCOSE TEST SET | CGA | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| February 2, 1981 | K810055 | STANBIO BILIRUBIN TEST SET | CIG | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| January 16, 1981 | K802832 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | LCP | Substantially Equivalent | Sandare Chemical Co., Inc. | accessdata.fda.gov |
| July 8, 1980 | K801422 | SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. | LCP | Substantially Equivalent | Sandare Chemical Co., Inc. | accessdata.fda.gov |
| October 3, 1978 | K781635 | CHLORIDE TEST SET, CAT.# 0210 | CHJ | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| November 3, 1977 | K771856 | DIR. QUANT. COLOR. DETERM. SERUM CREAT. | CGX | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 2, 2023 | 93300 | Class II | Ongoing | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. | Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can | accessdata.fda.gov |
| March 16, 2022 | 89829 | Class II | Terminated | Separation Technology Creamatocrit Plus, Catalog Number: | The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants) | accessdata.fda.gov |
| July 12, 2021 | 88323 | Class III | Terminated | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. | accessdata.fda.gov |
| February 13, 2018 | 79245 | Class II | Terminated | RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expir | All patient serum samples yield a weakly positive test result. | accessdata.fda.gov |
| February 8, 2018 | 80562 | Class II | Terminated | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts. | accessdata.fda.gov |
| September 18, 2006 | 36436 | Not yet classified | Terminated | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagn | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | accessdata.fda.gov |
Compare with other makers
- All makers of Microbial Nucleic Acid Storage And Stabilization Device
- All makers of Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- All makers of Reagent, Occult Blood
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
- All makers of Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- All makers of Calibrators, Drug Mixture
Updated December 6, 2023. 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.