Medical Device Manufacturer · US , San Diego , CA

General Biometrics, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1989

Total

Cleared

Denied

General Biometrics, Inc. has 23 FDA 510(k) cleared medical devices. Based in San Diego, US.

Historical record: 23 cleared submissions from 1989 to 1992. Primary specialty: Immunology.

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

General Biometrics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - General Biometrics, Inc.

23 devices

1-23 of 23

Cleared Dec 01, 1992

IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL

K924843 · LLL

Immunology · 64d

Cleared Aug 20, 1992

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST

K920400 · MID

Immunology · 204d

Cleared Aug 20, 1992

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

K920401 · MID

Immunology · 204d

Cleared Apr 08, 1992

IMMUNODOT BORRELIA (LYME) TEST

K911627 · LSR

Microbiology · 363d

Cleared Dec 30, 1991

IMMUNOWELL LYME (P39 RECOMBINANT) TEST

K911599 · LSR

Microbiology · 265d

Cleared Dec 20, 1991

IMMUNOWELL BORRELIA (LYME)TEST

K911590 · LSR

Microbiology · 255d

Cleared Dec 09, 1991

IMMUNOWELL DSDNA ANTIBODY TEST

K914801 · DHC

Immunology · 46d

Cleared May 07, 1991

IMMUNOWELL RNP/SM ANTIBODY TEST

K911848 · LKP

Immunology · 11d

Cleared May 07, 1991

IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST

K911849 · LKO

Immunology · 11d

Cleared May 07, 1991

IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST

K911850 · LKO

Immunology · 11d

Cleared May 07, 1991

IMMUNOWELL SM ANTIBODY TEST

K911851 · LKP

Immunology · 11d

Cleared Jan 25, 1991

IMMUNOWELL THYROGLOBULIN TEST

K905485 · JZO

Immunology · 50d

Cleared Jan 03, 1991

IMMUNOWELL TPO (MICROSOME) TEST

K905486 · JNL

Immunology · 28d

Cleared Oct 02, 1990

IMMUNODOT THYROID AUTOIMMUNITY PANEL

K903843 · JNL

Chemistry · 42d

Cleared Aug 09, 1990

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3

K902938 · LLL

Immunology · 37d

Cleared Aug 09, 1990

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4

K903047 · LLL

Immunology · 29d

Cleared Jan 24, 1990

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2

K900072 · LJM

Immunology · 19d

Cleared Dec 05, 1989

IMMUNODOT AUTOIMMUNE SCREENING PANEL 1

IMMUNODOT RUBELLA TEST

K894546 · LFX

Microbiology · 87d

Cleared Sep 13, 1989

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST

K894975 · KTN

Immunology · 37d

Cleared Feb 03, 1989

IMMUNODOT TORCH TEST RUBELLA

K884898 · LFX

Microbiology · 72d

Cleared Feb 02, 1989

IMMUNODOT RUBELLA TEST

K885082 · LFX

Microbiology · 55d

General Biometrics, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - General Biometrics, Inc.

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