ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT— 510(k) K935042

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K935042 for ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT, Substantially Equivalent on 1994-01-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 1993-10-21
Decision date: 1994-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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