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)

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

K-Number: K082118 · 2009-09-18

ApplicantCepheid
Decision Date2009-09-18
Product CodeNPQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2009-09-18 under 510(k) number K082118. The device is classified under product code NPQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPERT HEMOSIL FACTOR II & FACTOR V ASSAY?

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Cepheid. The 510(k) number is K082118.

When did XPERT HEMOSIL FACTOR II & FACTOR V ASSAY receive FDA 510(k) clearance?

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY received FDA 510(k) clearance on 2009-09-18, under 510(k) number K082118.

Who is the listed applicant for XPERT HEMOSIL FACTOR II & FACTOR V ASSAY?

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

What is the FDA product code for XPERT HEMOSIL FACTOR II & FACTOR V ASSAY?

The FDA product code for XPERT HEMOSIL FACTOR II & FACTOR V ASSAY is NPQ.

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 Cepheid 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.

K261336Xpert Respiratory PanelK261362Xpert Hemorrhagic FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert Xpress CoV-2/Flu/RSV plus

View all 55 devices →

Related Devices (Code: NPQ)

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.

K100980INVADER FACTOR VHologic, Inc.K093129ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR IIIllumina, Inc.K093974ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPINGOsmetech Molecular DiagnosticsK060564INFINITI SYSTEMAutoGenomics, 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.

↑