Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K971905 ↗

FDA Product Code

DEH

Device Class

Class II

Regulation

21 CFR Part 866.5550

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

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