Name: Predicase
Price: 199 USD

K-number	K202101
Device name	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
Applicant	Accriva Diagnostics, Inc.
Product code	JPA
Device class	Class II
Decision date	Dec 29, 2021
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2

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