Cleared Traditional

TINA-QUANT D-DIMER TEST SYSTEM

K062203 · Roche Diagnostics Corp. · Hematology
Mar 2007
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K062203 is an FDA 510(k) clearance for the TINA-QUANT D-DIMER TEST SYSTEM, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on March 14, 2007, 225 days after receiving the submission on August 1, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K062203 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2006
Decision Date March 14, 2007
Days to Decision 225 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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