CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160— 510(k) K080607

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K080607 for CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160, Substantially Equivalent on 2008-05-12. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2008-03-04
Decision date: 2008-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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