Tas Results Data Acquisition System (Traqs)
FDA 510(k) K981206 · Cardiovascular Diagnostics, Inc.
510(k) numberK981206
Submission
- Device name
- Tas Results Data Acquisition System (Traqs)
- Applicant
- Cardiovascular Diagnostics, Inc.
Raleigh, NC, US - Received
- April 1, 1998
- Decision date
- May 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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|---|---|---|---|
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…GKP · Special | Instrumentation Laboratory (IL) Co. | 08/16/2024SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | Instrumentation Laboratory Company | 06/21/2023SE |
| K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)GKP · Special | Instrumentation Laboratory CO | 03/03/2016SE |
| K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…GKP · Traditional | Instrumentation Laboratory CO | 12/13/2015SE |
| K091980 | Acl Top 700 LasGKP · Special | Instrumentation Laboratory CO | 09/22/2009SE |
| K073377 | Acl Top (with System Software V3.0.0)GKP · Traditional | Instrumentation Laboratory CO | 05/04/2008SE |
| K063679 | Acl TopGKP · Special | Instrumentation Laboratory CO | 01/12/2007SE |
| K033414 | Acl Top Model, TopGKP · Abbreviated | Instrumentation Laboratory CO | 01/12/2004SE |
| K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…GKP · Traditional | Dade Behring, Inc. | 09/08/2003SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | Fisher Diagnostics | 12/09/2002SE |
More from Fisher Diagnostics
| 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 |
| K990566 | Tas Analyzer, Model 1009JPA · Traditional | 05/14/1999SE |
| 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 Results Data Acquisition System (Traqs) cleared by the FDA?
Tas Results Data Acquisition System (Traqs) (K981206) received a 510(k) decision of Substantially Equivalent on May 26, 1998, 55 days after the submission was received.
What is the product code of K981206?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.