K-number	K192271
Device name	Access PCT, Access PCT Calibrators
Applicant	Beckman Coulter, Inc.
Product code	PTF
Device class	Class II
Decision date	Nov 26, 2019
Decision	Substantially Equivalent
Regulation	866.3215

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Source

View the full FDA submission: accessdata.fda.gov

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Access PCT, Access PCT Calibrators

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