ROCHE TDM CALIBRATION VERIFICATION TEST SET— 510(k) K942114

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K942114 for ROCHE TDM CALIBRATION VERIFICATION TEST SET, Substantially Equivalent on 1994-09-02. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIF
Advisory panel: Clinical Toxicology
Date received: 1994-05-03
Decision date: 1994-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.