COBAS INTEGRA HDL-CHOLESTEROL DIRECT— 510(k) K973284

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K973284 for COBAS INTEGRA HDL-CHOLESTEROL DIRECT, Substantially Equivalent on 1997-12-18. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 1997-09-02
Decision date: 1997-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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