ROCHE CALIBRATOR SERUM— 510(k) K942706

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K942706 for ROCHE CALIBRATOR SERUM, Substantially Equivalent on 1995-09-20. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1994-06-08
Decision date: 1995-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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