ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY— 510(k) K031756

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K031756 for ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY, Substantially Equivalent on 2003-06-25. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CGN
Advisory panel: Clinical Chemistry
Date received: 2003-06-06
Decision date: 2003-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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