Device Listing 1336453247
Listing Summary#
- Listing key
- 1336453247
- Premarket submission
- K202101
- Device
- 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
- Decision date
- 2021-12-29