DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA— 510(k) K900604

Name: FDA 510(k) clearance K900604
Creator: U.S. Food and Drug Administration
Published: 1990-07-26

Substantially Equivalent

Biovir Laboratories, Inc.

FDA 510(k) clearance K900604 for DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA, Substantially Equivalent on 1990-07-26. Applicant: Biovir Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biovir Laboratories, Inc.
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1990-02-08
Decision date: 1990-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

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