Candida Immunodiffusion System

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

510(k) Number

K812186 ↗

FDA Product Code

LHK

Device Class

Class II

Regulation

21 CFR Part 866.3165

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Streptacoccus Co-Agglutination Kit

  Class I

  FDA 510(k) K822799 Active Cleared 19 Dec 1982

• Dispo Fibrin Pipet Tips B4182-2

  Class II

  FDA 510(k) K820532 Active Cleared 8 Apr 1982

• Infectious Tissue Kit

  Not classified

  FDA 510(k) K864824 Active Cleared 24 Dec 1986

• Vaspar Sealent

  Class I

  FDA 510(k) K812191 Active Cleared 31 Aug 1981

• Smith's Systemic Fungal Medium

  Class I

  FDA 510(k) K812187 Active Cleared 31 Aug 1981

• Staphylococcus Latex Agglutination Kit

  Class I

  FDA 510(k) K820683 Active Cleared 14 Apr 1982

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