Data / Medical devices / United States / Biomerica
Biomerica: FDA-registered device maker in Irvine, CA, United States, 25 510(k) clearances
Biomerica is registered with the FDA (registration 2025099) in Irvine, CA, United States. It lists 28 device types. The FDA files 25 510(k) clearances under its listings, the newest dated December 15, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2025099
- FEI number
- 3007981058
- Address
- 17571 Von Karman Ave, Irvine, CA, United States, 92614
- Owner or operator
- Biomerica, Inc. (10023649)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- December 6, 2007
- Registered through
- 2027
- Brand names listed
- ACTH ELISA Kit, Aware Pad (Breast Self-Exam), COVID-19 Antigen Rapid Test (Nasopharyngeal Swab), COVID-19 Antigen Rapid Test (Oral Fluid), COVID-19 IgG/IgM Rapid Test, Calcitonin ELISA, EPO ELISA, EZ Detect 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K232892 | Hp Detect™ Stool Antigen ELISA | LYR | Substantially Equivalent | Biomerica, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 19, 2002 | K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | DRR | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| October 28, 2002 | K022589 | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, 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 8, 2002 | K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | MMI | Substantially Equivalent | Biocheck, 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 30, 2001 | K011353 | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 20, 2001 | K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | DCK | Substantially Equivalent | Biocheck, 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 |
| 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 |
| February 21, 2001 | K003856 | EZ-HCG URINE(PREGNANCY TEST) | JHI | Substantially Equivalent | Biomerica, Inc. | accessdata.fda.gov |
| June 7, 2000 | K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | GGT | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| July 20, 1999 | K991469 | AWARE PAD | IYO | Substantially Equivalent | Aac Consulting Group, Inc. | accessdata.fda.gov |
| September 3, 1998 | K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | JKR | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| August 19, 1998 | K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | CKG | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| December 23, 1997 | K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA | CEW | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| July 11, 1995 | K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | CEP | Substantially Equivalent | Syntron Bioresearch, Inc. | accessdata.fda.gov |
| March 4, 1992 | K915185 | GAP IGG H.PYLORI MODIFIED | LYR | Substantially Equivalent | Biomerica, Inc. | accessdata.fda.gov |
| April 7, 1986 | K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL | KHE | Substantially Equivalent | Self Care Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2014 | 69621 | Class II | Terminated | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum. | A potential issue with false high values. | accessdata.fda.gov |
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Updated December 15, 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.