MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA— 510(k) K042389

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K042389 for MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA, Substantially Equivalent on 2004-09-14. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2004-09-02
Decision date: 2004-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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