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)

FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

K-Number: K972288 · 1997-07-14

ApplicantUniversal Reagents, Inc.
Decision Date1997-07-14
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR DEFICIENT PLASMAS - FACTOR IX (9) is the device name listed in this FDA 510(k) record. The listed applicant is Universal Reagents, Inc.. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K972288. 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 FACTOR DEFICIENT PLASMAS - FACTOR IX (9)?

FACTOR DEFICIENT PLASMAS - FACTOR IX (9) is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Universal Reagents, Inc.. The 510(k) number is K972288.

When did FACTOR DEFICIENT PLASMAS - FACTOR IX (9) receive FDA 510(k) clearance?

FACTOR DEFICIENT PLASMAS - FACTOR IX (9) received FDA 510(k) clearance on 1997-07-14, under 510(k) number K972288.

Who is the listed applicant for FACTOR DEFICIENT PLASMAS - FACTOR IX (9)?

The FDA 510(k) record lists Universal Reagents, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACTOR DEFICIENT PLASMAS - FACTOR IX (9)?

The FDA product code for FACTOR DEFICIENT PLASMAS - FACTOR IX (9) 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 Universal Reagents, 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.

K973143UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMAK972286FACTOR DEFICIENT PLASMAS - FACTOR XI (11)K970593UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMAK970607UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMAK964270UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMAK964459UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA

View all 8 devices →

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.

↑