Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test
FDA 510(k) K993519 · Cardiovascular Diagnostics, Inc.
510(k) numberK993519
Submission
- Device name
- Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test
- Applicant
- Cardiovascular Diagnostics, Inc.
Raleigh, NC, US - Received
- October 18, 1999
- Decision date
- January 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOX – Analyzer, Heparin, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5680
- Specialty
- Hematology
Other 510(k)s with product code JOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111339 | Hemostasis Managment System Plus (Hms-Plus)JOX · Special | Medtronic, Inc. | 06/08/2011SE |
| K102953 | Heparin Dose Response CartridgeJOX · Special | Medtronic, Inc. | 11/04/2010SE |
| K101271 | Hemostasis Management System Plus (HMS Plus ), Model 305 XXJOX · Special | Medtronic, Inc. | 10/13/2010SE |
| K051040 | Heparin Dose Response Controls, Model 306-20 PorJOX · Special | Medtronic Perfusion Systems | 05/24/2005SE |
| K043080 | Heparin Dose Response Controls, Model 306-20 PorJOX · Special | Medtronic Vascular | 12/03/2004SE |
| K042070 | Heparin Dose Response Cartridge, Model 304-20JOX · Special | Medtronic Vascular | 10/01/2004SE |
| K922031 | HMS Purple and Black Heparin Cartridges & ControlJOX · Traditional | Medtronic Hemotec, Inc. | 07/21/1992SE |
| K911240 | Hepcon HMS with Body Surface Area CalculationJOX · Traditional | Hemotech, Inc. | 07/17/1991SE |
| K894317 | Hemotec Hepcon HMS Coagulation System & Access.JOX · Traditional | Hemotec, Inc. | 09/05/1989SE |
| K854377 | Hemotec CV Whole Blood Coagulation ControlsJOX · Traditional | Hemotec, Inc. | 12/04/1985SE |
More from Hemotec, 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 |
| K990566 | Tas Analyzer, Model 1009JPA · Traditional | 05/14/1999SE |
| 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 Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test cleared by the FDA?
Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test (K993519) received a 510(k) decision of Substantially Equivalent on January 14, 2000, 88 days after the submission was received.
What is the product code of K993519?
The FDA product code is JOX – Analyzer, Heparin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5680.