EL-ANA PROFILES: ANTI-CHROMATIN— 510(k) K040291

Substantially Equivalent

Theratest Laboratories, Inc.

FDA 510(k) clearance K040291 for EL-ANA PROFILES: ANTI-CHROMATIN, Substantially Equivalent on 2004-03-11. Applicant: Theratest Laboratories, Inc..

Clearance details

Applicant: Theratest Laboratories, Inc.
Product code: Code LJM
Advisory panel: Immunology
Date received: 2004-02-06
Decision date: 2004-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lombard, IL, US

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