Tas Analyzer, Model 1009
FDA 510(k) K990566 · Cardiovascular Diagnostics, Inc.
510(k) numberK990566
Submission
- Device name
- Tas Analyzer, Model 1009
- Applicant
- Cardiovascular Diagnostics, Inc.
Raleigh, NC, US - Received
- February 22, 1999
- Decision date
- May 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| 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 |
|---|---|---|
| K013305 | Enoxaparin Test CardKFF · Traditional | 08/23/2002SE |
| K994194 | (Tas) Low Range Heparin Management Card RapidpointJBP · Traditional | 03/28/2000SE |
| K994159 | HMP Controls (Tas) RapidpointGGN · Traditional | 02/15/2000SE |
| K993519 | Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag…JOX · Traditional | 01/14/2000SE |
| K981206 | Tas Results Data Acquisition System (Traqs)GKP · Traditional | 05/26/1998SE |
| K981178 | Thrombolytic Assessment System Low Range Heparin Management Test ControlsGGN · Traditional | 04/27/1998SE |
| K971748 | Tas Pt-Nctest ControlsGGN · Traditional | 05/29/1997SE |
| K961814 | Thrombolytic Assessment System Prothrombin Time Test ControlsGIZ · Traditional | 08/13/1996SE |
| K961189 | Tas a PTT Test ControlsGGN · Traditional | 06/05/1996SE |
| K960234 | Tas HMT ControlsGGN · Traditional | 05/30/1996SE |
Questions and answers
When was Tas Analyzer, Model 1009 cleared by the FDA?
Tas Analyzer, Model 1009 (K990566) received a 510(k) decision of Substantially Equivalent on May 14, 1999, 81 days after the submission was received.
What is the product code of K990566?
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.