ROCHE REAGENT FOR APOLIPOPROTEIN B— 510(k) K910552

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K910552 for ROCHE REAGENT FOR APOLIPOPROTEIN B, Substantially Equivalent on 1991-05-07. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code MSJ
Advisory panel: Clinical Chemistry
Date received: 1991-02-07
Decision date: 1991-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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