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FDA 510(k)

WEST NILE DETECT IGM ELISA

K-Number: K041817 · 2004-11-19

ApplicantInbios Intl., Inc.
Decision Date2004-11-19
Product CodeNOP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WEST NILE DETECT IGM ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inbios Intl., Inc.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K041817. 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 DETECT IGM ELISA?

WEST NILE DETECT IGM ELISA is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Inbios Intl., Inc.. The 510(k) number is K041817.

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

WEST NILE DETECT IGM ELISA received FDA 510(k) clearance on 2004-11-19, under 510(k) number K041817.

Who is the listed applicant for WEST NILE DETECT IGM ELISA?

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

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

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

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Other records listing Inbios Intl., Inc. as applicant

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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.K041068WEST NILE VIRUS IGG INDIRECT ELISAPanbio LimitedK041231WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02MPanbio LimitedK040854WEST NILE VIRUS IGM CAPTURE ELISAFocus Technologies, 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.

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