Cleared Special

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K051040 · Medtronic Perfusion Systems · Hematology
May 2005
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K051040 is an FDA 510(k) clearance for the HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR, a Analyzer, Heparin, Automated (Class II — Special Controls, product code JOX), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on May 24, 2005, 29 days after receiving the submission on April 25, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.

Submission Details

510(k) Number K051040 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2005
Decision Date May 24, 2005
Days to Decision 29 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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