EMDS CREATINE KINASE ITEM NIMBER 65411— 510(k) K893691

Name: FDA 510(k) clearance K893691
Creator: U.S. Food and Drug Administration
Published: 1989-08-31

Substantially Equivalent

Diagnostic Systems

FDA 510(k) clearance K893691 for EMDS CREATINE KINASE ITEM NIMBER 65411, Substantially Equivalent on 1989-08-31. Applicant: Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Diagnostic Systems
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1989-05-16
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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