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General Biometrics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELDecember 1, 1992
K920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTAugust 20, 1992
K920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTAugust 20, 1992
K911627IMMUNODOT BORRELIA (LYME) TESTApril 8, 1992
K911599IMMUNOWELL LYME (P39 RECOMBINANT) TESTDecember 30, 1991
K911590IMMUNOWELL BORRELIA (LYME)TESTDecember 20, 1991
K914801IMMUNOWELL DSDNA ANTIBODY TESTDecember 9, 1991
K911851IMMUNOWELL SM ANTIBODY TESTMay 7, 1991
K911849IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TESTMay 7, 1991
K911848IMMUNOWELL RNP/SM ANTIBODY TESTMay 7, 1991
K911850IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TESTMay 7, 1991
K905485IMMUNOWELL THYROGLOBULIN TESTJanuary 25, 1991
K905486IMMUNOWELL TPO (MICROSOME) TESTJanuary 3, 1991
K903843IMMUNODOT THYROID AUTOIMMUNITY PANELOctober 2, 1990
K902938IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3August 9, 1990
K903047IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4August 9, 1990
K900072IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2January 24, 1990
K896347IMMUNODOT AUTOIMMUNE SCREENING PANEL 1December 5, 1989
K894410IMMUNODOT LYME TESTOctober 30, 1989
K894546IMMUNODOT RUBELLA TESTOctober 16, 1989