FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES— 510(k) K863798

Name: FDA 510(k) clearance K863798
Creator: U.S. Food and Drug Administration
Published: 1987-04-14

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K863798 for FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES, Substantially Equivalent on 1987-04-14. 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: 1986-09-29
Decision date: 1987-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

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