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Genbio

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K010301 IMMUNOWELL EA (D) IGG TESTLSE2001-06-11 View
510(k) K974226 IMMUNODOT MONO-G TESTLSE1998-09-22 View
510(k) K974244 IMMUNODOT MONO-M TESTLSE1998-09-22 View
510(k) K973940 IMMUNOWELL EBV VCA IGG TESTLSE1998-08-10 View
510(k) K973939 IMMUNOWELL VCA IGM TESTLJN1998-08-10 View
510(k) K973941 IMMUNOWELL EBNA IGG TESTLLM1998-08-10 View
510(k) K963054 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)LJZ1997-05-05 View
510(k) K963055 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120LJZ1997-05-02 View
510(k) K953682 IMMUNO DOT BORRELIA DOT BLOT G TESTLSR1996-05-03 View
510(k) K953683 MMUNO DOT BORRELIA DOT BLOT M TESTLSR1996-05-03 View
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