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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Cell Standards, Inc.. It received FDA 510(k) clearance on 2022-08-15 under 510(k) 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. The listed applicant is Boston Cell Standards, Inc.. The 510(k) number is K220163.

When did Her-2, ER, PR IHControls receive FDA 510(k) clearance?

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

Who is the listed applicant for Her-2, ER, PR IHControls?

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

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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