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)

WEST NILE VIRUS IGM CAPTURE ELISA

K-Number: K040854 · 2004-06-30

ApplicantFocus Technologies, Inc.
Decision Date2004-06-30
Product CodeNOP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WEST NILE VIRUS IGM CAPTURE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Focus Technologies, Inc.. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K040854. The device is classified under product code NOP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEST NILE VIRUS IGM CAPTURE ELISA?

WEST NILE VIRUS IGM CAPTURE ELISA is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Focus Technologies, Inc.. The 510(k) number is K040854.

When did WEST NILE VIRUS IGM CAPTURE ELISA receive FDA 510(k) clearance?

WEST NILE VIRUS IGM CAPTURE ELISA received FDA 510(k) clearance on 2004-06-30, under 510(k) number K040854.

Who is the listed applicant for WEST NILE VIRUS IGM CAPTURE ELISA?

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

What is the FDA product code for WEST NILE VIRUS IGM CAPTURE ELISA?

The FDA product code for WEST NILE VIRUS IGM CAPTURE ELISA is NOP.

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 Focus Technologies, 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.

K031953WEST NILE VIRUS ELISA IGG, MODEL EL0300GK031952WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300MK021486HERPESELECT 2 ELISA IGG, MODEL ELO920GK021429HERPESELECT 1 ELISA IGG, MODEL EL0910G

Related Devices (Code: NOP)

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.

K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc.K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)Euroimmun Us, Inc.K052519SPECTRAL WEST NILE VIRUS IGM STATUS TESTSpectral Diagnostics, Inc.K041817WEST NILE DETECT IGM ELISAInbios Intl., Inc.K041068WEST NILE VIRUS IGG INDIRECT ELISAPanbio LimitedK041231WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02MPanbio Limited

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.

↑