K-number	K213348
Device name	BOND MMR Antibody Panel
Applicant	Leica Biosystems Newcastle, Ltd.
Product code	PZJ
Device class	Class II
Decision date	Feb 21, 2023
Decision	Substantially Equivalent
Regulation	864.1866

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Source

View the full FDA submission: accessdata.fda.gov

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BOND MMR Antibody Panel

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