3M ANTI-CARDIOLIPIN FAST(TM) TEST— 510(k) K913054

Name: FDA 510(k) clearance K913054
Creator: U.S. Food and Drug Administration
Published: 1991-11-27

Substantially Equivalent

3M Diagnostic Systems, Inc.

FDA 510(k) clearance K913054 for 3M ANTI-CARDIOLIPIN FAST(TM) TEST, Substantially Equivalent on 1991-11-27. Applicant: 3M Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: 3M Diagnostic Systems, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1991-07-09
Decision date: 1991-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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