K945523

Substantially Equivalent

COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS

Applicant: Roche Diagnostic Systems, Inc.
Product code: LCQ
Advisory panel: Clinical Toxicology
Date received: 1994-11-10
Decision date: 1995-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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