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FDA 510(k)

NOVA Lite DAPI dsDNA Crithidia luciliae Kit

K-Number: K192916 · 2020-12-11

ApplicantInova Diagnostics, Inc.
Decision Date2020-12-11
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NOVA Lite DAPI dsDNA Crithidia luciliae Kit is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-12-11 under approval number K192916. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA Lite DAPI dsDNA Crithidia luciliae Kit?

NOVA Lite DAPI dsDNA Crithidia luciliae Kit is a medical device that received FDA 510(k) clearance on 2020-12-11. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K192916.

When was NOVA Lite DAPI dsDNA Crithidia luciliae Kit approved by the FDA?

NOVA Lite DAPI dsDNA Crithidia luciliae Kit received FDA 510(k) clearance on 2020-12-11, under approval number K192916.

What company makes NOVA Lite DAPI dsDNA Crithidia luciliae Kit?

NOVA Lite DAPI dsDNA Crithidia luciliae Kit is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for NOVA Lite DAPI dsDNA Crithidia luciliae Kit?

The FDA product code for NOVA Lite DAPI dsDNA Crithidia luciliae Kit is KTL.

Other Devices by Inova Diagnostics, Inc.

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Related Devices (Code: KTL)

K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc. K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc. K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.

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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