PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA— 510(k) K992900

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K992900 for PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL 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: 1999-08-30
Decision date: 1999-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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