ROCHE COBAS READY AMYLASE REAGENT— 510(k) K903309

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K903309 for ROCHE COBAS READY AMYLASE REAGENT, Substantially Equivalent on 1990-09-07. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1990-07-24
Decision date: 1990-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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