MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB— 510(k) K022654

Name: FDA 510(k) clearance K022654
Creator: U.S. Food and Drug Administration
Published: 2002-08-29

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K022654 for MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB, Substantially Equivalent on 2002-08-29. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2002-08-09
Decision date: 2002-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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