ELECSYS FOLATE III— 510(k) K141426

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K141426 for ELECSYS FOLATE III, Substantially Equivalent on 2014-10-17. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CGN
Advisory panel: Clinical Chemistry
Date received: 2014-05-30
Decision date: 2014-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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