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Amico Lab, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K842662ANTI-EPSTEIN-BARR VIRUS KITDecember 12, 1985
K842529AMIZYME-CMV KITDecember 6, 1985
K842531AMIZYME-HSV TYPES 1 & 2 TEST KITSDecember 6, 1985
K842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2December 6, 1985
K842661ANTI-CYTOMEGALOVIRUS KITDecember 6, 1985
K842530AMIZYME-EBV TEST KITDecember 6, 1985
K842660ANTI-SCHISTOSOMA SPECIES KITOctober 30, 1984
K842658ANTI-CHLAMYDIA TRACHOMATIS KITOctober 1, 1984
K842525AMIZYME-C TRACHOMATIS TEST KITOctober 1, 1984
K842533AMIZYME-ANDNA TEST KITSeptember 20, 1984
K842532AMIZYME-ANA TEST KITSeptember 20, 1984
K842528AMIZYME-TOXOPLASMA GONDII KITSeptember 7, 1984
K842527AMIZYME-SCHISTOSOMA SPP. TEST KITSeptember 5, 1984
K842526AMIZYME-LEISHMANIA SPP. TEST KITAugust 28, 1984
K842664ANTI-TOXOPLASMA GONDII KITAugust 28, 1984
K840024WHEELCHAIR MECHANICALJanuary 30, 1984
K822681ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)December 13, 1982
K822682ANTI-NATIVE (DOUBLE STANDARD) DNA TEST KDecember 3, 1982
K822677FITC ANTISERA TO HUMAN IGMNovember 17, 1982
K822679FITC ANTISERA TO HUMAN C3November 17, 1982