MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR— 510(k) K871680

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K871680 for MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR, Substantially Equivalent on 1987-06-08. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LAN
Advisory panel: Clinical Toxicology
Date received: 1987-04-29
Decision date: 1987-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

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