COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA— 510(k) K843828

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K843828 for COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA, Substantially Equivalent on 1985-02-01. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LFW
Advisory panel: Clinical Toxicology
Date received: 1984-09-28
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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