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FDA 510(k)

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

K-Number: K043451 · 2005-03-17

ApplicantHyphen Biomed
Decision Date2005-03-17
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA 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 2005-03-17 under 510(k) number K043451. 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 NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR?

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR is a medical device that received FDA 510(k) clearance on 2005-03-17. The listed applicant is Hyphen Biomed. The 510(k) number is K043451.

When did BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR receive FDA 510(k) clearance?

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR received FDA 510(k) clearance on 2005-03-17, under 510(k) number K043451.

Who is the listed applicant for BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA 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 NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR?

The FDA product code for BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR is GGN.

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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, RK040AK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6K050365BIOPHEN 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 # 221105

Related Devices (Code: GGN)

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.

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, 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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