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FDA 510(k)

FluChip-8G Influenza A+B Assay

K-Number: K182513 · 2019-04-22

ApplicantIndevr, Inc.
Decision Date2019-04-22
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FluChip-8G Influenza A+B Assay is a medical device manufactured by Indevr, Inc.. It received FDA 510(k) clearance on 2019-04-22 under approval number K182513. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FluChip-8G Influenza A+B Assay?

FluChip-8G Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2019-04-22. It is manufactured by Indevr, Inc.. The 510(k) number is K182513.

When was FluChip-8G Influenza A+B Assay approved by the FDA?

FluChip-8G Influenza A+B Assay received FDA 510(k) clearance on 2019-04-22, under approval number K182513.

What company makes FluChip-8G Influenza A+B Assay?

FluChip-8G Influenza A+B Assay is manufactured by Indevr, Inc..

What is the FDA product code for FluChip-8G Influenza A+B Assay?

The FDA product code for FluChip-8G Influenza A+B Assay is OZE.

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Official Source

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