510(k) K971902— ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT

Substantially Equivalent

Roche Diagnostic Systems, Inc.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LBS
Advisory panel: Clinical Chemistry
Date received: 1997-05-23
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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