Gammadab[125]Ege Radioimmunoassay It

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K821092 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Gammadab Lh Radio-Kit #ca-1508

  Class I

  FDA 510(k) K823476 Active Cleared 28 Dec 1982

• In Vitro T-3 Uptake Test

  Class II

  FDA 510(k) K770480 Active Cleared 6 Apr 1977

• Gastrin Radioimmunoassay Test

  Class I

  FDA 510(k) K810722 Active Cleared 27 May 1981

• Ria Kit, Gammacoat

  Class II

  FDA 510(k) K782109 Active Cleared 26 Jan 1979

• IV Vitro Gammadab T4 Ria Kit

  Class II

  FDA 510(k) K781235 Active Cleared 14 Aug 1978

• In Vitro T3 Ria Test

  Class II

  FDA 510(k) K772108 Active Cleared 17 Nov 1977

See all devices from Clinical Assays, Inc. →