ROCHE-TDM ONLEIN(TM) CONTROLS— 510(k) K946119

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K946119 for ROCHE-TDM ONLEIN(TM) CONTROLS, Substantially Equivalent on 1995-02-07. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LAS
Advisory panel: Clinical Toxicology
Date received: 1994-12-15
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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