Cleared Traditional

IMMUNOCAP RAPID READER, MODEL 12-3600-10

K092978 · Phadia US, Inc. · Immunology
Jan 2010
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K092978 is an FDA 510(k) clearance for the IMMUNOCAP RAPID READER, MODEL 12-3600-10, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on January 19, 2010, 113 days after receiving the submission on September 28, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K092978 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2009
Decision Date January 19, 2010
Days to Decision 113 days
Submission Type Traditional
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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