K-number	K220163
Device name	Her-2, ER, PR IHControls
Applicant	Boston Cell Standards, Inc.
Product code	NJW
Device class	Class II
Decision date	Aug 15, 2022
Decision	Substantially Equivalent
Regulation	864.1860

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View the full FDA submission: accessdata.fda.gov

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Her-2, ER, PR IHControls

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