Cleared Traditional

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

K161646 · Diazyme Laboratories · Chemistry
Nov 2016
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K161646 is an FDA 510(k) clearance for the Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 4, 2016, 142 days after receiving the submission on June 15, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K161646 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2016
Decision Date November 04, 2016
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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