Cleared Traditional

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

K091984 · Siemens Medical Solutions Diagnostics · Immunology
Oct 2009
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K091984 is an FDA 510(k) clearance for the IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Siemens Medical Solutions Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on October 28, 2009, 118 days after receiving the submission on July 2, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K091984 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2009
Decision Date October 28, 2009
Days to Decision 118 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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