Cleared Special

IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H

K131738 · Phadia AB · Immunology
Jul 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K131738 is an FDA 510(k) clearance for the IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 10, 2013, 27 days after receiving the submission on June 13, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K131738 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2013
Decision Date July 10, 2013
Days to Decision 27 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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