EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK— 510(k) K861061

Name: FDA 510(k) clearance K861061
Creator: U.S. Food and Drug Administration
Published: 1986-04-24

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K861061 for EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK, Substantially Equivalent on 1986-04-24. 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: 1986-03-20
Decision date: 1986-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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