COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C— 510(k) K851032

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K851032 for COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C, Substantially Equivalent on 1985-04-03. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1985-03-12
Decision date: 1985-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, NJ, US

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