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
FDA 510(k) clearance K202101 · decided 2021-12-29
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-29
- Decision date
- 2021-12-29
- Days to decision
- 518 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 recall (Z-2460-2026) | Accriva Diagnostics, Inc. | 2026-06-16 |