ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)— 510(k) K972214

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K972214 for ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN), Substantially Equivalent on 1997-06-24. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1997-06-12
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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