Vma Assay Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K843379 ↗

FDA Product Code

CDF

Device Class

Class I

Regulation

21 CFR Part 862.1795

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K880692 Active Cleared 27 May 1988

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  Class II

  FDA 510(k) K875208 Active Cleared 18 Apr 1988

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  Class II

  FDA 510(k) K843378 Active Cleared 14 Sep 1984

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