ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN— 510(k) K083260

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K083260 for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN, Substantially Equivalent on 2009-10-16. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code DDR
Advisory panel: Immunology
Date received: 2008-11-05
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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