K-number	K200754
Device name	Hemosure Accu-Reader A100
Applicant	W.H.P.M., Inc.
Product code	OOX
Device class	Class II
Decision date	Jun 2, 2022
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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Hemosure Accu-Reader A100

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