K-number	K992228
Device name	BAYER IMMUNO 1 HER-2/NEU ASSAY
Applicant	Bayer Corp.
Product code	NCW
Device class	Class II
Decision date	Sep 29, 2000
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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BAYER IMMUNO 1 HER-2/NEU ASSAY

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