Immunogl. Frct. of Rabbit Antiser.-Alpha

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K812495 ↗

FDA Product Code

DEW

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Rabbit Antiserum to Human C4

  Class II

  FDA 510(k) K831906 Active Cleared 19 Jul 1983

• Dako Pap Kit K504

  Class II

  FDA 510(k) K812485 Active Cleared 10 Feb 1982

• Staining System for Pneumocystis Carinii

  Class II

  FDA 510(k) K905504 Active Cleared 28 Jun 1991

• Dako Monoclonal Mouse Anti-Human Estrogen Receptor

  Class II

  FDA 510(k) K993957 Active Cleared 3 Mar 2000

• Dako Elisa Rotavirus Kit- 96 Tests K440

  Class I

  FDA 510(k) K912666 Active Cleared 14 Feb 1992

• Rabbit Antiserum to Human Kappa Light

  Class II

  FDA 510(k) K831904 Active Cleared 19 Jul 1983

See all devices from Dako Corp. →