Cleared Special

HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200

K080322 · Hycor Biomedical, Inc. · Immunology
Mar 2008
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K080322 is an FDA 510(k) clearance for the HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 5, 2008, 28 days after receiving the submission on February 6, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K080322 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2008
Decision Date March 05, 2008
Days to Decision 28 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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