Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

General Biometrics, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K924843 IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELLLL1992-12-01 View
510(k) K920401 IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTMID1992-08-20 View
510(k) K920400 IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTMID1992-08-20 View
510(k) K911627 IMMUNODOT BORRELIA (LYME) TESTLSR1992-04-08 View
510(k) K911599 IMMUNOWELL LYME (P39 RECOMBINANT) TESTLSR1991-12-30 View
510(k) K911590 IMMUNOWELL BORRELIA (LYME)TESTLSR1991-12-20 View
510(k) K914801 IMMUNOWELL DSDNA ANTIBODY TESTDHC1991-12-09 View
510(k) K911849 IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TESTLKO1991-05-07 View
510(k) K911848 IMMUNOWELL RNP/SM ANTIBODY TESTLKP1991-05-07 View
510(k) K911851 IMMUNOWELL SM ANTIBODY TESTLKP1991-05-07 View
510(k) K911850 IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TESTLKO1991-05-07 View
510(k) K905485 IMMUNOWELL THYROGLOBULIN TESTJZO1991-01-25 View
510(k) K905486 IMMUNOWELL TPO (MICROSOME) TESTJNL1991-01-03 View
510(k) K903843 IMMUNODOT THYROID AUTOIMMUNITY PANELJNL1990-10-02 View
510(k) K902938 IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3LLL1990-08-09 View
510(k) K903047 IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4LLL1990-08-09 View
510(k) K900072 IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2LJM1990-01-24 View
510(k) K896347 IMMUNODOT AUTOIMMUNE SCREENING PANEL 1LJM1989-12-05 View
510(k) K894410 IMMUNODOT LYME TESTLSR1989-10-30 View
510(k) K894546 IMMUNODOT RUBELLA TESTLFX1989-10-16 View
↑