CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360— 510(k) K062319

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K062319 for CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360, Substantially Equivalent on 2006-09-13. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2006-08-09
Decision date: 2006-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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