ENCORE ENA COMBINED EIA— 510(k) K931543

Name: FDA 510(k) clearance K931543
Creator: U.S. Food and Drug Administration
Published: 1993-09-08

Substantially Equivalent

Clark Laboratories, Inc.

FDA 510(k) clearance K931543 for ENCORE ENA COMBINED EIA, Substantially Equivalent on 1993-09-08. Applicant: Clark Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Clark Laboratories, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1993-03-29
Decision date: 1993-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blairstown, NJ, US

Download summary PDF View on FDA.gov ↗

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