EA-D IGG ELISA TEST SYSTEM— 510(k) K973123

Name: FDA 510(k) clearance K973123
Creator: U.S. Food and Drug Administration
Published: 1998-03-26

Substantially Equivalent

Clark Laboratories, Inc.

FDA 510(k) clearance K973123 for EA-D IGG ELISA TEST SYSTEM, Substantially Equivalent on 1998-03-26. 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: 1997-08-20
Decision date: 1998-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

Download summary PDF View on FDA.gov ↗

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