General Biometrics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL, IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST, IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Biometrics, Inc. Immunology ✕
15 devices
Cleared
Dec 01, 1992
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
Immunology
64d
Cleared
Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
Immunology
204d
Cleared
Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
Immunology
204d
Cleared
Dec 09, 1991
IMMUNOWELL DSDNA ANTIBODY TEST
Immunology
46d
Cleared
May 07, 1991
IMMUNOWELL RNP/SM ANTIBODY TEST
Immunology
11d
Cleared
May 07, 1991
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
Immunology
11d
Cleared
May 07, 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
Immunology
11d
Cleared
May 07, 1991
IMMUNOWELL SM ANTIBODY TEST
Immunology
11d
Cleared
Jan 25, 1991
IMMUNOWELL THYROGLOBULIN TEST
Immunology
50d
Cleared
Jan 03, 1991
IMMUNOWELL TPO (MICROSOME) TEST
Immunology
28d
Cleared
Aug 09, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
Immunology
37d
Cleared
Aug 09, 1990
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
Immunology
29d