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 the device name listed in this FDA 510(k) record. The listed applicant is Konan Medical, Inc.. It received FDA 510(k) clearance on 2021-06-15 under 510(k) 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. The listed applicant is Konan Medical, Inc.. The 510(k) number is K203244.

When did CellChek 20 rc receive FDA 510(k) clearance?

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

Who is the listed applicant for CellChek 20 rc?

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

What is the FDA product code for CellChek 20 rc?

The FDA product code for CellChek 20 rc is NFJ.

Other records listing Konan Medical, 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.

K191558Konan Specular Microscope XVII

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.