Immuchem Covalent-Coat

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822140 ↗

FDA Product Code

JKC

Device Class

Class I

Regulation

21 CFR Part 862.1245

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Luteinizing Hormone (Lh-Irma) Ria Kit

  Class I

  FDA 510(k) K864144 Active Cleared 24 Nov 1986

• Estradiol Kit by Ria

  Class I

  FDA 510(k) K820329 Active Cleared 4 Mar 1982

• Thyroid Stimulating Hormone (Htsh) Irma Neonatal

  Class II

  FDA 510(k) K883726 Active Cleared 15 Dec 1988

• Immuchem Covalent Coat Solid Phase Assay

  Class II

  FDA 510(k) K791663 Active Cleared 1 Oct 1979

• Thyroid Stimulating Hormone (Tsh Irma) Ria Kit

  Class II

  FDA 510(k) K865071 Active Cleared 13 Mar 1987

• Immuchem Covalent-Coat Ria Kit

  Class II

  FDA 510(k) K830962 Active Cleared 4 May 1983

See all devices from Immuchem Corp. →