COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS— 510(k) K952555

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K952555 for COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS, Substantially Equivalent on 1995-07-31. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code MOJ
Advisory panel: Clinical Toxicology
Date received: 1995-06-02
Decision date: 1995-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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