Platelet Function Test Assay Cartridges for the Hepcon HMS
FDA 510(k) K954202 · Medtronic Hemotec, Inc.
510(k) numberK954202
Submission
- Device name
- Platelet Function Test Assay Cartridges for the Hepcon HMS
- Applicant
- Medtronic Hemotec, Inc.
Parker, CO, US - Received
- September 7, 1995
- Decision date
- June 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Expedited review
- Yes
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code JPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253658 | STA Satellite Max®JPA · Traditional | Diagnostica Stago, Inc. | 04/27/2026SE |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional | Sysmex America, Inc. | 06/02/2025SE |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics Corporation | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | Haemonetics Corporation | 03/29/2024SE |
| K233790 | Acl Top 970 CLJPA · Special | Instrumentation Laboratory | 12/29/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | Instrumentation Laboratory CO | 09/29/2023SE |
| K212183 | STA R Max 3, STA Compact Max 3JPA · Traditional | Diagnostica Stago S.A.S | 06/07/2023SE |
| K201440 | ROTEM sigma Thromboelastometry SystemJPA · Traditional | Tem Innovations GmbH | 07/08/2022SE |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional | Accriva Diagnostics, Inc. | 12/29/2021SE |
More from Accriva Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944115 | Heparin Assay Cartridges and ControlsGFT · Traditional | 03/24/1995SE |
| K940426 | Medtronic Hemotec Act II Automated Coagulation TimerGKN · Traditional | 09/20/1994SE |
| K923594 | Clottrac Coagulation ControlJBP · Traditional | 09/21/1992SE |
| K922031 | HMS Purple and Black Heparin Cartridges & ControlJOX · Traditional | 07/21/1992SE |
Questions and answers
When was Platelet Function Test Assay Cartridges for the Hepcon HMS cleared by the FDA?
Platelet Function Test Assay Cartridges for the Hepcon HMS (K954202) received a 510(k) decision of Substantially Equivalent on June 20, 1996, 287 days after the submission was received.
What is the product code of K954202?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.