Home / Companies / Genbio

Genbio

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K010301IMMUNOWELL EA (D) IGG TESTJune 11, 2001
K974226IMMUNODOT MONO-G TESTSeptember 22, 1998
K974244IMMUNODOT MONO-M TESTSeptember 22, 1998
K973939IMMUNOWELL VCA IGM TESTAugust 10, 1998
K973940IMMUNOWELL EBV VCA IGG TESTAugust 10, 1998
K973941IMMUNOWELL EBNA IGG TESTAugust 10, 1998
K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)May 5, 1997
K963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120May 2, 1997
K953682IMMUNO DOT BORRELIA DOT BLOT G TESTMay 3, 1996
K953683MMUNO DOT BORRELIA DOT BLOT M TESTMay 3, 1996