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FDA 510(k)

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

K-Number: K052519 · 2006-11-30

ApplicantSpectral Diagnostics, Inc.
Decision Date2006-11-30
Product CodeNOP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPECTRAL WEST NILE VIRUS IGM STATUS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Diagnostics, Inc.. It received FDA 510(k) clearance on 2006-11-30 under 510(k) number K052519. 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 SPECTRAL WEST NILE VIRUS IGM STATUS TEST?

SPECTRAL WEST NILE VIRUS IGM STATUS TEST is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K052519.

When did SPECTRAL WEST NILE VIRUS IGM STATUS TEST receive FDA 510(k) clearance?

SPECTRAL WEST NILE VIRUS IGM STATUS TEST received FDA 510(k) clearance on 2006-11-30, under 510(k) number K052519.

Who is the listed applicant for SPECTRAL WEST NILE VIRUS IGM STATUS TEST?

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

What is the FDA product code for SPECTRAL WEST NILE VIRUS IGM STATUS TEST?

The FDA product code for SPECTRAL WEST NILE VIRUS IGM STATUS TEST is NOP.

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Other records listing Spectral Diagnostics, 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.

K030057SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESTK022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTK020950SPECTRAL'S 2 IN 1 (TNI-MYO)K014105SPECTRAL'S TROPONIN IK992127CARDIOQUANT TROPONIN I TESTK991447CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

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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.K041817WEST NILE DETECT IGM ELISAInbios Intl., 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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