Name: Predicase
Price: 199 USD

K-number	K173202
Device name	CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
Applicant	Sekisui Medical Co., Ltd.
Product code	JPA
Device class	Class II
Decision date	May 9, 2018
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

Everything you need for a 510(k) submission. Nothing you don't.