MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM— 510(k) K993971

Name: FDA 510(k) clearance K993971
Creator: U.S. Food and Drug Administration
Published: 2000-01-11

Substantially Equivalent

Micro Detect, Inc.

FDA 510(k) clearance K993971 for MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM, Substantially Equivalent on 2000-01-11. Applicant: Micro Detect, Inc.. Device class: 2.

Clearance details

Applicant: Micro Detect, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1999-11-23
Decision date: 2000-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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