Cleared Traditional

DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET

K112120 · Diazyme Laboratories · Hematology
Jan 2013
Decision
549d
Days
Class 2
Risk

About This 510(k) Submission

K112120 is an FDA 510(k) clearance for the DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 24, 2013, 549 days after receiving the submission on July 25, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K112120 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2011
Decision Date January 24, 2013
Days to Decision 549 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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