ROTAVIRUS BIO-ENZABEAD SCREEN KIT— 510(k) K834443

Name: FDA 510(k) clearance K834443
Creator: U.S. Food and Drug Administration
Published: 1984-03-16

Substantially Equivalent

Litton Bionetics

FDA 510(k) clearance K834443 for ROTAVIRUS BIO-ENZABEAD SCREEN KIT, Substantially Equivalent on 1984-03-16. Applicant: Litton Bionetics. Device class: 1.

Clearance details

Applicant: Litton Bionetics
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1983-12-16
Decision date: 1984-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05

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K801720 — TOXO BIO-BEAD TITRATION KIT1980-09-16

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