510(k) K926222
- Device
- OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K926222
- Product code
- JPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-02-12
- Date received
- 1992-12-10
- Regulation
- 864.5425
- Classification name
- System, Multipurpose For In Vitro Coagulation Studies
- Medical specialty
- Hematology
- Review panel
- Hematology
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code JPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026-04-27 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | 2025-06-02 |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | 2025-04-30 |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | 2025-01-15 |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | 2024-03-29 |
| K233790 | ACL TOP 970 CL | Instrumentation Laboratory | 2023-12-29 |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Instrumentation Laboratory CO | 2023-09-29 |
| K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | 2023-06-07 |
| K201440 | ROTEM sigma Thromboelastometry System | Tem Innovations GmbH | 2022-07-08 |
| K202101 | 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 | Accriva Diagnostics, Inc. | 2021-12-29 |
| K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019-11-22 |
| K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | 2019-08-21 |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation | 2019-05-09 |
| K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set | Sekisui Medical Co., Ltd. | 2018-05-09 |
| K172286 | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Products GmbH | 2017-12-18 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases