COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT— 510(k) K982848

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K982848 for COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT, Substantially Equivalent on 1998-10-01. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1998-08-12
Decision date: 1998-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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