Cleared Traditional

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

K071255 · Hyphen Biomed · Hematology
Sep 2007
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K071255 is an FDA 510(k) clearance for the ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A, a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on September 7, 2007, 126 days after receiving the submission on May 4, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K071255 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2007
Decision Date September 07, 2007
Days to Decision 126 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code LCO — Platelet Factor 4 Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7695

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