CREATINE KINASE MB TEST ITEM NUMBER 5A46— 510(k) K914361

Name: FDA 510(k) clearance K914361
Creator: U.S. Food and Drug Administration
Published: 1991-12-13

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K914361 for CREATINE KINASE MB TEST ITEM NUMBER 5A46, Substantially Equivalent on 1991-12-13. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1991-10-01
Decision date: 1991-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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