Cleared Special

IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

K133404 · Phadia AB · Immunology
Feb 2014
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K133404 is an FDA 510(k) clearance for the IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Phadia AB (Portae, US). The FDA issued a Cleared decision on February 24, 2014, 110 days after receiving the submission on November 6, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K133404 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2013
Decision Date February 24, 2014
Days to Decision 110 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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