COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS— 510(k) K871484

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K871484 for COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS, Substantially Equivalent on 1987-05-28. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LGS
Advisory panel: Clinical Toxicology
Date received: 1987-04-15
Decision date: 1987-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, NJ, US

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