Cleared Traditional

DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET

K133083 · Diazyme Laboratories · Immunology
Jun 2014
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K133083 is an FDA 510(k) clearance for the DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on June 24, 2014, 267 days after receiving the submission on September 30, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K133083 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2013
Decision Date June 24, 2014
Days to Decision 267 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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