K-number	K182793
Device name	AP3600 Automated Instrument
Applicant	Hitachi Chemical Diagnostics, Inc.
Product code	DHB
Device class	Class II
Decision date	Mar 19, 2019
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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AP3600 Automated Instrument

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