CYTOMEGELISA M TEST KIT— 510(k) K854839

Name: FDA 510(k) clearance K854839
Creator: U.S. Food and Drug Administration
Published: 1986-02-04

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K854839 for CYTOMEGELISA M TEST KIT, Substantially Equivalent on 1986-02-04. Applicant: Whittaker Bioproducts, Inc.. Device class: 2.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1985-12-04
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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