Diagnostic Kits & Kit Components

510(k) Number

K812434 ↗

FDA Product Code

LHT

Device Class

Class I

Regulation

21 CFR Part 866.3700

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• H. Influenza B Antisera for Cie

  Class II

  FDA 510(k) K823348 Active Cleared 28 Dec 1982

• Ease-A-Cult

  Class II

  FDA 510(k) K002756 Active Cleared 23 Feb 2001

• Buffer, Collagen Reagent and Diluent (JBX)

  Class II

  FDA 510(k) K781710 Active Cleared 24 Oct 1978

• Anti-Human IgG Serum

  Class II

  FDA 510(k) K791281 Active Cleared 27 Nov 1979

• Anti-Human Kappa Serum

  Class II

  FDA 510(k) K791284 Active Cleared 27 Nov 1979

• Aspergillus Fumigatus, Aspergillus Flavu

  Class I

  FDA 510(k) K790672 Active Cleared 31 May 1979

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