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FDA 510(k)

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

K-Number: K161258 · 2017-02-03

ApplicantInova Diagnostics, Inc.
Decision Date2017-02-03
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-02-03 under approval number K161258. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit?

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is a medical device that received FDA 510(k) clearance on 2017-02-03. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K161258.

When was NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit approved by the FDA?

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit received FDA 510(k) clearance on 2017-02-03, under approval number K161258.

What company makes NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit?

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit?

The FDA product code for NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is MOB.

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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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