FDA 510(k)

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

K-Number: K051472 · 2005-12-23

Decision Date2005-12-23

Product CodeGGN

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hyphen Biomed. It received FDA 510(k) clearance on 2005-12-23 under 510(k) number K051472. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR?

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR is a medical device that received FDA 510(k) clearance on 2005-12-23. The listed applicant is Hyphen Biomed. The 510(k) number is K051472.

When did BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR receive FDA 510(k) clearance?

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR received FDA 510(k) clearance on 2005-12-23, under 510(k) number K051472.

Who is the listed applicant for BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR?

The FDA 510(k) record lists Hyphen Biomed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR?

The FDA product code for BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR is GGN.

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Other records listing Hyphen Biomed as applicant

K071255ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A K050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 K050365BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 K043451BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

Related Devices (Code: GGN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.