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FDA 510(k)

Her-2, ER, PR IHControls

K-Number: K220163 · 2022-08-15

ApplicantBoston Cell Standards, Inc.
Decision Date2022-08-15
Product CodeNJW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Her-2, ER, PR IHControls is a medical device manufactured by Boston Cell Standards, Inc.. It received FDA 510(k) clearance on 2022-08-15 under approval number K220163. The device is classified under product code NJW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Her-2, ER, PR IHControls?

Her-2, ER, PR IHControls is a medical device that received FDA 510(k) clearance on 2022-08-15. It is manufactured by Boston Cell Standards, Inc.. The 510(k) number is K220163.

When was Her-2, ER, PR IHControls approved by the FDA?

Her-2, ER, PR IHControls received FDA 510(k) clearance on 2022-08-15, under approval number K220163.

What company makes Her-2, ER, PR IHControls?

Her-2, ER, PR IHControls is manufactured by Boston Cell Standards, Inc..

What is the FDA product code for Her-2, ER, PR IHControls?

The FDA product code for Her-2, ER, PR IHControls is NJW.

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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