Company ยท US
Accriva Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
7recalls (4 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2023 | K223352 | Tenderfoot Accriva Diagnostics, Inc. | FMK |
| Dec 29, 2021 | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activa Accriva Diagnostics, Inc. | JPA |
| Nov 22, 2019 | K193041 | Hemochron Signature Elite Accriva Diagnostics, Inc. | JPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Accriva Diagnostics, Inc. Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103 Open, Classified |
JPA | K940401 |
| Jun 16, 2026 | Accriva Diagnostics, Inc. directCHECK ACT-LR whole blood quality control, level 2
Model/Catalog Number: DCGLR-2 Open, Classified |
GGN | K202101 |
| Dec 3, 2025 | Accriva Diagnostics, Inc. Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System Open, Classified |
JBP | K960749 |
| Nov 13, 2025 | Accriva Diagnostics, Inc. VerifyNow PRUTest Platelet Reactivity Test REF 85225
UDI-DI code: 10711234150078
The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of pl Open, Classified |
JOZ | K141427 |
| Jan 16, 2025 | Accriva Diagnostics, Inc. VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 Open, Classified |
JOZ | None listed |
| Oct 31, 2024 | Accriva Diagnostics, Inc. AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. Completed |
DQA | K922075 |
| Mar 30, 2022 | Accriva Diagnostics, Inc. The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, in Terminated |
JOZ | K141427 |