FDA 510(k)

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

K-Number: K043007 · 2005-11-07

Decision Date2005-11-07

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 is the device name listed in this FDA 510(k) record. The listed applicant is Hyphen Biomed. It received FDA 510(k) clearance on 2005-11-07 under 510(k) number K043007. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105?

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 is a medical device that received FDA 510(k) clearance on 2005-11-07. The listed applicant is Hyphen Biomed. The 510(k) number is K043007.

When did BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 receive FDA 510(k) clearance?

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 received FDA 510(k) clearance on 2005-11-07, under 510(k) number K043007.

Who is the listed applicant for BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105?

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 ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105?

The FDA product code for BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 is JBQ.

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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 K051472BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR K043451BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

Related Devices (Code: JBQ)

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH K081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare Diagnostics K070301HEMOSIL ANTITHROMBINInstrumentation Laboratory CO K062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory CO K033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO K023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50Precision Biologic

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.