THERATEST EL-ANA PROFILES TEST SYSTEM— 510(k) K950716

Name: FDA 510(k) clearance K950716
Creator: U.S. Food and Drug Administration
Published: 1995-09-26

Substantially Equivalent

Theratest Laboratories, Inc.

FDA 510(k) clearance K950716 for THERATEST EL-ANA PROFILES TEST SYSTEM, Substantially Equivalent on 1995-09-26. Applicant: Theratest Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Theratest Laboratories, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-01-31
Decision date: 1995-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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