ELECSYS RBC FOLATE HEMOLYZED REAGENT— 510(k) K051292

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K051292 for ELECSYS RBC FOLATE HEMOLYZED REAGENT, Substantially Equivalent on 2005-06-17. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CGN
Advisory panel: Clinical Chemistry
Date received: 2005-05-18
Decision date: 2005-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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