Cleared Traditional

ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS

K082340 · Roche Diagnostics Corp. · Chemistry

Jun 2009

Decision

308d

Days

Class 2

Risk

About This 510(k) Submission

K082340 is an FDA 510(k) clearance for the ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on June 19, 2009, 308 days after receiving the submission on August 15, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number	K082340 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2008
Decision Date	June 19, 2009
Days to Decision	308 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF