3M ANTI-DSDNA FAST TEST— 510(k) K913653

Name: FDA 510(k) clearance K913653
Creator: U.S. Food and Drug Administration
Published: 1991-11-07

Substantially Equivalent

3M Diagnostic Systems, Inc.

FDA 510(k) clearance K913653 for 3M ANTI-DSDNA FAST TEST, Substantially Equivalent on 1991-11-07. Applicant: 3M Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: 3M Diagnostic Systems, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1991-08-16
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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