TDM CONTROL SET— 510(k) K060429

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K060429 for TDM CONTROL SET, Substantially Equivalent on 2006-03-15. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2006-02-21
Decision date: 2006-03-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

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