Name: Predicase
Price: 199 USD

K-number	K183160
Device name	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
Applicant	Haemonetics Corporation
Product code	JPA
Device class	Class II
Decision date	May 9, 2019
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

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