Medical Device Manufacturer · US , Newport Beach , CA

Biomerica, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1991

Total

Cleared

Denied

Biomerica, Inc. has 10 FDA 510(k) cleared medical devices. Based in Newport Beach, US.

Last cleared in 2023. Active since 1991. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Biomerica, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Biomerica, Inc.

10 devices

1-10 of 10

Cleared Dec 15, 2023

Hp Detect™ Stool Antigen ELISA

K232892 · LYR

Microbiology · 88d

Cleared Feb 21, 2001

EZ-HCG URINE(PREGNANCY TEST)

K003856 · JHI

Chemistry · 70d

Cleared Sep 24, 1998

FREE T4 MICROWELL EIA, MODEL #7019

K982954 · CEC

Chemistry · 31d

Cleared Sep 19, 1996

TSH (MICROWELL) ELISA

K962216 · JLW

Chemistry · 101d

Cleared Mar 19, 1996

T-3 MICROWELL EIA MODEL 7013

T4 MICROWELL EIA (ENZYME IMMUNOASSAY0

K950588 · KLI

Chemistry · 140d

Cleared Jul 18, 1994

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY

K936010 · DDC

Immunology · 214d

Cleared Mar 04, 1992

GAP IGG H.PYLORI MODIFIED

Biomerica, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Biomerica, Inc.

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