Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

K-Number: K050365 · 2005-12-27

ApplicantHyphen Biomed
Decision Date2005-12-27
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 is the device name listed in this FDA 510(k) record. The listed applicant is Hyphen Biomed. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K050365. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202?

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Hyphen Biomed. The 510(k) number is K050365.

When did BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 receive FDA 510(k) clearance?

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 received FDA 510(k) clearance on 2005-12-27, under 510(k) number K050365.

Who is the listed applicant for BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202?

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 PROTEIN C5, C2.5, MODELS 221205, 221202?

The FDA product code for BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 is GGP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 6K051472BIOPHEN 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: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

Official Source

View on FDA Database →

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

↑