Incstar Corp. - FDA 510(k) Cleared Devices
58
Total
57
Cleared
0
Denied
FDA 510(k) Regulatory Record - Incstar Corp. Microbiology ✕
15 devices
Cleared
May 01, 1997
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
Microbiology
253d
Cleared
Dec 16, 1996
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
Microbiology
117d
Cleared
Dec 16, 1996
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
Microbiology
117d
Cleared
Oct 24, 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
Microbiology
273d
Cleared
Oct 24, 1996
INCSTAR RUBELLA IGG ELISA ASSAY
Microbiology
273d
Cleared
Oct 17, 1996
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
Microbiology
260d
Cleared
Jul 24, 1996
INCSTAR HSV I/II IGG FAST ELISA ASSAY
Microbiology
245d
Cleared
Jul 24, 1996
INCSTAR HSZ I/II IGG ELISA ASSAY
Microbiology
245d
Cleared
Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
Microbiology
243d
Cleared
Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
Microbiology
243d
Cleared
Jun 09, 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
Microbiology
183d
Cleared
Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
Microbiology
181d
Cleared
Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
Microbiology
181d
Cleared
Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
Microbiology
161d
Cleared
Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
Microbiology
127d