Medical Device Manufacturer · US , Mchenry , IL

Immuchem Corp. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1979
18
Total
18
Cleared
0
Denied

FDA 510(k) Regulatory Record - Immuchem Corp. Chemistry

18 devices
1-18 of 18
Cleared Dec 15, 1988
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
K883726 · JLW
Chemistry · 106d
Cleared May 20, 1987
FOLLICLE STIMULATING HORMONE (HFSH)
K871317 · CGJ
Chemistry · 48d
Cleared May 14, 1987
HPROLACTIN KIT
K871542 · CFT
Chemistry · 24d
Cleared Mar 13, 1987
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
K865071 · JLW
Chemistry · 74d
Cleared Nov 24, 1986
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K864144 · CEP
Chemistry · 33d
Cleared Mar 14, 1986
ANDROSTENEDIONE 125I KIT BY RIA
K860559 · CIZ
Chemistry · 28d
Cleared Feb 28, 1986
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · JLS
Chemistry · 144d
Cleared May 04, 1983
IMMUCHEM COVALENT-COAT RIA KIT
K830962 · DPO
Chemistry · 37d
Cleared Sep 28, 1982
COVALENT COAT RIA KIT
K822509 · CFP
Chemistry · 39d
Cleared Aug 05, 1982
IMMUCHEM COVALENT-COAT
K822140 · JKC
Chemistry · 16d
Cleared Mar 04, 1982
ESTRADIOL KIT BY RIA
K820329 · CHP
Chemistry · 24d
Cleared Dec 22, 1981
PROGESTERONE KIT BY RIA
K813484 · JLS
Chemistry · 21d
Cleared Jun 18, 1981
DIRECT TESTOSTERONE RIA
K811536 · CDZ
Chemistry · 17d
Cleared May 29, 1981
EARLY PREGNANCY DETECTION
K811398 · JHI
Chemistry · 11d
Cleared Aug 27, 1980
TESTOSTERONE KIT
K801666 · CDZ
Chemistry · 37d
Cleared Oct 01, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791663 · CDP
Chemistry · 41d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT BINDING
K791662 · KHQ
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791664 · CDX
Chemistry · 37d
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