Elsa-Prol Immunoradiometric Assay Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K860823 ↗

FDA Product Code

CFT

Device Class

Class I

Regulation

21 CFR Part 862.1625

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cesium 137 Source, Model Csm-40

  Class II

  FDA 510(k) K882449 Active Cleared 14 Apr 1989

• Elsa-Pth

  Class II

  FDA 510(k) K950211 Active Cleared 13 Apr 1995

• Tshk-Nn Ria Kit

  Class II

  FDA 510(k) K860824 Active Cleared 28 Apr 1986

• Irradiator for Biological Materials, Ibl-137C

  Unclassified

  FDA 510(k) K865027 Active Cleared 26 Feb 1987

• Personnel Protective Shield

  Class I

  FDA 510(k) K871502 Active Cleared 8 May 1987

• Elsa-Hct

  Class II

  FDA 510(k) K951708 Active Cleared 5 Sep 1995

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