510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Biomerica

Irvine, CA, US

Biomerica appears in FDA device records in Irvine, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Biomerica between 1991 and 2023. The busiest year on record is 1995, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biomerica, by decision year
YearClearances
19911
19921
19941
19952
19962
19981
20011
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232892Hp Detect™ Stool Antigen ELISALYRSubstantially Equivalent
K003856EZ-HCG URINE(PREGNANCY TEST)JHISubstantially Equivalent
K982954FREE T4 MICROWELL EIA, MODEL #7019CECSubstantially Equivalent
K962216TSH (MICROWELL) ELISAJLWSubstantially Equivalent
K960412T-3 MICROWELL EIA MODEL 7013CDPSubstantially Equivalent
K954256ANTI-TPOJNLSubstantially Equivalent
K950588T4 MICROWELL EIA (ENZYME IMMUNOASSAY0KLISubstantially Equivalent
K936010THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAYDDCSubstantially Equivalent
K915185GAP IGG H.PYLORI MODIFIEDLYRSubstantially Equivalent
K900343GAP-IGGLYRSubstantially Equivalent

Registered establishments

FDA registered establishments for Biomerica, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20250993007981058Biomerica17571 Von Karman Ave, Irvine, CA 92614 US2026and 18 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0467-2015Calcitonin 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain