ROCHE CALIBRATOR SERUM— 510(k) K922043

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K922043 for ROCHE CALIBRATOR SERUM, Substantially Equivalent on 1992-06-16. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1992-05-01
Decision date: 1992-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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