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FDA 510(k)

CellChek 20 rc

K-Number: K203244 · 2021-06-15

Decision Date2021-06-15
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CellChek 20 rc is a medical device manufactured by Konan Medical, Inc.. It received FDA 510(k) clearance on 2021-06-15 under approval number K203244. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CellChek 20 rc?

CellChek 20 rc is a medical device that received FDA 510(k) clearance on 2021-06-15. It is manufactured by Konan Medical, Inc.. The 510(k) number is K203244.

When was CellChek 20 rc approved by the FDA?

CellChek 20 rc received FDA 510(k) clearance on 2021-06-15, under approval number K203244.

What company makes CellChek 20 rc?

CellChek 20 rc is manufactured by Konan Medical, Inc..

What is the FDA product code for CellChek 20 rc?

The FDA product code for CellChek 20 rc is NFJ.

Other Devices by Konan Medical, Inc.

Related Devices (Code: NFJ)

Official Source

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