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Incstar Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
58
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYMay 1, 1997
K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)December 16, 1996
K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)December 16, 1996
K960367INCSTAR RUBELLA IGG ELISA ASSAYOctober 24, 1996
K960358INCSTAR RUBELLA IGG FAST ELISA ASSAYOctober 24, 1996
K960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530October 17, 1996
K953567INCSTAR 25-HYDROXYVITMIN D 1251 RIASeptember 25, 1996
K955363INCSTAR HSZ I/II IGG ELISA ASSAYJuly 24, 1996
K955362INCSTAR HSV I/II IGG FAST ELISA ASSAYJuly 24, 1996
K955361INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAYJuly 22, 1996
K955360INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAYJuly 22, 1996
K951639COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)October 13, 1995
K946158INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KITJune 9, 1995
K946159INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KITJune 7, 1995
K946157INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KITJune 7, 1995
K941168CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KITSeptember 7, 1994
K940271INCSTAR ACTH IRMAAugust 2, 1994
K935075SPQ CRP CONTROL LEVEL IIJanuary 11, 1994
K934966SPQ PAL CONTROL LEVEL IIJanuary 11, 1994
K934521SPQ MALB CONTROL LEVEL IINovember 26, 1993