ROCHE AMMONIA (VARIOUS)— 510(k) K942048

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K942048 for ROCHE AMMONIA (VARIOUS), Substantially Equivalent on 1994-10-04. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKB
Advisory panel: Clinical Toxicology
Date received: 1994-04-28
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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