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FDA 510(k)

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

K-Number: K050367 · 2006-05-24

ApplicantHyphen Biomed
Decision Date2006-05-24
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 is the device name listed in this FDA 510(k) record. The listed applicant is Hyphen Biomed. It received FDA 510(k) clearance on 2006-05-24 under 510(k) number K050367. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6?

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 is a medical device that received FDA 510(k) clearance on 2006-05-24. The listed applicant is Hyphen Biomed. The 510(k) number is K050367.

When did BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 receive FDA 510(k) clearance?

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 received FDA 510(k) clearance on 2006-05-24, under 510(k) number K050367.

Who is the listed applicant for BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6?

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 HEPARIN 3, BIOPHEN HEPARIN 6?

The FDA product code for BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 is KFF.

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Other records listing Hyphen Biomed as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071255ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AK050365BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202K051472BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATORK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105K043451BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

Related Devices (Code: KFF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK013305ENOXAPARIN TEST CARDCardiovascular Diagnostics, Inc.

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.

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