MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA— 510(k) K041227

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K041227 for MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA, Substantially Equivalent on 2004-05-27. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2004-05-10
Decision date: 2004-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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