ROCHE ELECSYS ANTI-TG— 510(k) K053426

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K053426 for ROCHE ELECSYS ANTI-TG, Substantially Equivalent on 2006-02-07. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JZO
Advisory panel: Immunology
Date received: 2005-12-08
Decision date: 2006-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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