Cleared Special

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

K103716 · Roche Diagnostics · Chemistry
May 2011
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K103716 is an FDA 510(k) clearance for the ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on May 12, 2011, 142 days after receiving the submission on December 21, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K103716 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2010
Decision Date May 12, 2011
Days to Decision 142 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGN — Acid, Folic, Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1295

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