Cleared Traditional

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

K051472 · Hyphen Biomed · Hematology
Dec 2005
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K051472 is an FDA 510(k) clearance for the BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on December 23, 2005, 203 days after receiving the submission on June 3, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K051472 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2005
Decision Date December 23, 2005
Days to Decision 203 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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