PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA— 510(k) K993360

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K993360 for PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA, Substantially Equivalent on 1999-11-24. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1999-10-06
Decision date: 1999-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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