Cleared Special

HEPARIN DOSE RESPONSE CARTRIDGE

K102953 · Medtronic, Inc. · Hematology
Nov 2010
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K102953 is an FDA 510(k) clearance for the HEPARIN DOSE RESPONSE CARTRIDGE, a Analyzer, Heparin, Automated (Class II — Special Controls, product code JOX), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on November 4, 2010, 31 days after receiving the submission on October 4, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.

Submission Details

510(k) Number K102953 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2010
Decision Date November 04, 2010
Days to Decision 31 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOX — Analyzer, Heparin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5680

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