CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)— 510(k) K990460

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K990460 for CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), Substantially Equivalent on 1999-03-22. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1999-02-12
Decision date: 1999-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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