ELECSYS PRECICONTROL MULTIANALYTE— 510(k) K033937

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033937 for ELECSYS PRECICONTROL MULTIANALYTE, Substantially Equivalent on 2004-01-07. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2003-12-19
Decision date: 2004-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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