Medical Device Manufacturer · US , San Diego , CA

General Biometrics, Inc.

23 submissions · 23 cleared · Since 1989
23
Total
23
Cleared
0
Denied

General Biometrics, Inc. — FDA 510(k) Submissions

General Biometrics, Inc. has submitted 23 FDA 510(k) premarket notifications since 1989, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Borrelia Serological Reagent, Enzyme Linked Immunoabsorbent Assay, Rubella, Extractable Antinuclear Antibody, Antigen And Control, System, Test, Anticardiolipin Immunological, Antinuclear Antibody (enzyme-labeled), Antigen, Controls . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
K924843 · LLL Extractable Antinuclear... · Immunology
Dec 1992 64d
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
K920400 · MID System, Test,... · Immunology
Aug 1992 204d
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
K920401 · MID System, Test,... · Immunology
Aug 1992 204d
IMMUNODOT BORRELIA (LYME) TEST
K911627 · LSR Reagent, Borrelia... · Microbiology
Apr 1992 363d
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599 · LSR Reagent, Borrelia... · Microbiology
Dec 1991 265d
IMMUNOWELL BORRELIA (LYME)TEST
K911590 · LSR Reagent, Borrelia... · Microbiology
Dec 1991 255d
IMMUNOWELL DSDNA ANTIBODY TEST
K914801 · DHC System, Test, Systemic... · Immunology
Dec 1991 46d
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · LKP Anti-sm Antibody, Antigen... · Immunology
May 1991 11d
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · LKO Anti-rnp Antibody,... · Immunology
May 1991 11d
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · LKO Anti-rnp Antibody,... · Immunology
May 1991 11d
IMMUNOWELL SM ANTIBODY TEST
K911851 · LKP Anti-sm Antibody, Antigen... · Immunology
May 1991 11d
IMMUNOWELL THYROGLOBULIN TEST
K905485 · JZO System, Test, Thyroid... · Immunology
Jan 1991 50d
IMMUNOWELL TPO (MICROSOME) TEST
K905486 · JNL Immunochemical,... · Immunology
Jan 1991 28d
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843 · JNL Immunochemical,... · Chemistry
Oct 1990 42d
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
K902938 · LLL Extractable Antinuclear... · Immunology
Aug 1990 37d
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
K903047 · LLL Extractable Antinuclear... · Immunology
Aug 1990 29d
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · LJM Antinuclear Antibody... · Immunology
Jan 1990 19d
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347 · LJM Antinuclear Antibody... · Immunology
Dec 1989 32d
IMMUNODOT LYME TEST
K894410 · LSR Reagent, Borrelia... · Microbiology
Oct 1989 105d
IMMUNODOT RUBELLA TEST
K894546 · LFX Enzyme Linked... · Microbiology
Oct 1989 87d
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
K894975 · KTN System, Test, Infectious... · Immunology
Sep 1989 37d
IMMUNODOT TORCH TEST RUBELLA
K884898 · LFX Enzyme Linked... · Microbiology
Feb 1989 72d
IMMUNODOT RUBELLA TEST
K885082 · LFX Enzyme Linked... · Microbiology
Feb 1989 55d
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