Incstar Corp. - FDA 510(k) Cleared Devices
58
Total
57
Cleared
0
Denied
FDA 510(k) Regulatory Record - Incstar Corp. Chemistry ✕
11 devices
Cleared
Sep 25, 1996
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
Chemistry
422d
Cleared
Sep 07, 1994
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
Chemistry
177d
Cleared
Aug 02, 1994
INCSTAR ACTH IRMA
Chemistry
193d
Cleared
Nov 26, 1993
SPQ MALB CONTROL LEVEL II
Chemistry
70d
Cleared
May 14, 1992
N-TACT(R) PTH SP KIT
Chemistry
38d
Cleared
Jan 28, 1992
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
Chemistry
67d
Cleared
Jan 27, 1992
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
Chemistry
46d
Cleared
Jul 16, 1990
PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
Chemistry
94d
Cleared
Nov 21, 1989
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
Chemistry
204d
Cleared
Oct 17, 1989
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
Chemistry
69d
Cleared
Nov 23, 1987
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
Chemistry
34d