(Tas) Low Range Heparin Management Card Rapidpoint
FDA 510(k) K994194 · Cardiovascular Diagnostics, Inc.
510(k) numberK994194
Submission
- Device name
- (Tas) Low Range Heparin Management Card Rapidpoint
- Applicant
- Cardiovascular Diagnostics, Inc.
Raleigh, NC, US - Received
- December 13, 1999
- Decision date
- March 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JBP – Activated Whole Blood Clotting Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7140
- Specialty
- Hematology
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|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerJBP · Special | Sienco, Inc. | 01/04/2023SE |
| K062604 | Rapidteg Teg-Act TestJBP · Traditional | Haemoscope Corp. | 01/31/2007SE |
| K032952 | Aiact KitJBP · Traditional | Sienco, Inc. | 12/12/2003SE |
| K023582 | I-Stat Kaolin Act TestJBP · Traditional | I-Stat Corporation | 09/08/2003SE |
| K020914 | Actalyke XL Activated Clotting Time Analyzer, Model 5770JBP · Traditional | Helena Laboratories | 05/23/2002SE |
| K013078 | Actalyke Mini Activated Clotting Time Test System, Model 5750/5752JBP · Traditional | Helena Laboratories | 01/10/2002SE |
| K002528 | Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer OptionJBP · Special | Sienco, Inc. | 08/31/2000SE |
| K992571 | I-Stat SystemJBP · Traditional | I-Stat Corp. | 02/10/2000SE |
| K992851 | Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro SystemJBP · Traditional | Roche Diagnostics Corp. | 01/14/2000SE |
| K984141 | Gbact + KitJBP · Special | Sienco, Inc. | 05/28/1999SE |
More from Sienco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013305 | Enoxaparin Test CardKFF · Traditional | 08/23/2002SE |
| 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 |
| 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 (Tas) Low Range Heparin Management Card Rapidpoint cleared by the FDA?
(Tas) Low Range Heparin Management Card Rapidpoint (K994194) received a 510(k) decision of Substantially Equivalent on March 28, 2000, 106 days after the submission was received.
What is the product code of K994194?
The FDA product code is JBP – Activated Whole Blood Clotting Time, a Class II (moderate risk) device regulated under 21 CFR 864.7140.