ROCHE COBAS READY HDL CHOLESTEROL REAGENT— 510(k) K902935

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K902935 for ROCHE COBAS READY HDL CHOLESTEROL REAGENT, Substantially Equivalent on 1990-09-27. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JHM
Advisory panel: Clinical Chemistry
Date received: 1990-07-03
Decision date: 1990-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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