ROCHE REAGENT FOR LDH— 510(k) K900121

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K900121 for ROCHE REAGENT FOR LDH, Substantially Equivalent on 1990-03-30. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CFJ
Advisory panel: Clinical Chemistry
Date received: 1990-01-09
Decision date: 1990-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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