PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS— 510(k) K040280

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K040280 for PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS, Substantially Equivalent on 2004-03-11. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2004-02-06
Decision date: 2004-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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