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)

B-FACT, BORDERLINE FACTOR ASSAY CONTROL

K-Number: K945854 · 1995-10-24

ApplicantGeorge King Bio-Medical, Inc.
Decision Date1995-10-24
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

B-FACT, BORDERLINE FACTOR ASSAY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K945854. 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 B-FACT, BORDERLINE FACTOR ASSAY CONTROL?

B-FACT, BORDERLINE FACTOR ASSAY CONTROL is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K945854.

When did B-FACT, BORDERLINE FACTOR ASSAY CONTROL receive FDA 510(k) clearance?

B-FACT, BORDERLINE FACTOR ASSAY CONTROL received FDA 510(k) clearance on 1995-10-24, under 510(k) number K945854.

Who is the listed applicant for B-FACT, BORDERLINE FACTOR ASSAY CONTROL?

The FDA 510(k) record lists George King Bio-Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-FACT, BORDERLINE FACTOR ASSAY CONTROL?

The FDA product code for B-FACT, BORDERLINE FACTOR ASSAY CONTROL is GGN.

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 George King Bio-Medical, Inc. 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.

K161316George King Coumadin PlasmaK945855A-FACT, ABNORMAL FACTOR ASSAY CONTROLK945857PROTEIN C DEFICIENT PLASMAK945856POSITIVE LUPUS ANTICOAGULANT PLASMA

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

View on FDA Database →

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

↑