Immuchem Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALDecember 15, 1988
K871317FOLLICLE STIMULATING HORMONE (HFSH)May 20, 1987
K871542HPROLACTIN KITMay 14, 1987
K865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITMarch 13, 1987
K864144LUTEINIZING HORMONE (LH-IRMA) RIA KITNovember 24, 1986
K860559ANDROSTENEDIONE 125I KIT BY RIAMarch 14, 1986
K854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOASFebruary 28, 1986
K830962IMMUCHEM COVALENT-COAT RIA KITMay 4, 1983
K822509COVALENT COAT RIA KITSeptember 28, 1982
K822140IMMUCHEM COVALENT-COATAugust 5, 1982
K820329ESTRADIOL KIT BY RIAMarch 4, 1982
K813484PROGESTERONE KIT BY RIADecember 22, 1981
K811536DIRECT TESTOSTERONE RIAJune 18, 1981
K811398EARLY PREGNANCY DETECTIONMay 29, 1981
K801666TESTOSTERONE KITAugust 27, 1980
K791663IMMUCHEM COVALENT COAT SOLID PHASE ASSAYOctober 1, 1979
K791664IMMUCHEM COVALENT COAT SOLID PHASE ASSAYSeptember 27, 1979
K791662IMMUCHEM COVALENT COAT BINDINGSeptember 27, 1979