Dako Pap Kit K504

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K812485 ↗

FDA Product Code

DFH

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

• 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

• Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/Rpe

  Class II

  FDA 510(k) K961435 Active Cleared 14 Jun 1996

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