VCA IGG ELISA TEST SYSTEM— 510(k) K980912

Name: FDA 510(k) clearance K980912
Creator: U.S. Food and Drug Administration
Published: 1998-07-22

Substantially Equivalent

Clark Laboratories, Inc.

FDA 510(k) clearance K980912 for VCA IGG ELISA TEST SYSTEM, Substantially Equivalent on 1998-07-22. Applicant: Clark Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Clark Laboratories, Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1998-03-10
Decision date: 1998-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

Download summary PDF View on FDA.gov ↗

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