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Immunoprobe, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMDecember 22, 1997
K971393MYCOPLASMA IGG ELISA TEST SYSTEMJuly 14, 1997
K961764PR-3 ELISA TEST SYSTEMAugust 19, 1996
K961765MPO ELISA TEST SYSTEMAugust 19, 1996
K951549EBNA IGG EIA TEST SYSTEMApril 29, 1996
K952522CARDIOLIPIN IGA EIA TEST SYSTEMFebruary 9, 1996
K952523CARDIOLIPIN IGG EIA TEST KITFebruary 9, 1996
K952521CARDIOLIPIN IGM EIA TEST SYSTEMFebruary 9, 1996
K951362THYROGLOBULIN EIA TEST KITNovember 20, 1995
K951364MICROSOMAL EIA TEST KITNovember 20, 1995
K951363CARDIOLIPIN IGG,M,A EIA TEST SYSTEMOctober 13, 1995
K952520CARDIOLIPIN IGG,M,A EIA TEST KITSeptember 15, 1995
K941358THYROGLOBULIN EIA TEST KITMay 11, 1994
K941361MICROSOMAL EIA TEST KITMay 11, 1994