510(k) K202101 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
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., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 29, 2021 |
| Received | Jul 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2026 | Accriva Diagnostics, Inc. directCHECK ACT-LR whole blood quality control, level 2
Model/Catalog Number: DCGLR-2 Open, Classified |
GGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.