ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA— 510(k) K925826

Name: FDA 510(k) clearance K925826
Creator: U.S. Food and Drug Administration
Published: 1993-01-26

Substantially Equivalent

Clark Laboratories, Inc.

FDA 510(k) clearance K925826 for ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA, Substantially Equivalent on 1993-01-26. Applicant: Clark Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Clark Laboratories, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1992-11-16
Decision date: 1993-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blairstown, NJ, US

Download summary PDF View on FDA.gov ↗

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