Thrombolytic Assessment System Low Range Heparin Management Test Controls
FDA 510(k) K981178 · Cardiovascular Diagnostics, Inc.
510(k) numberK981178
Submission
- Device name
- Thrombolytic Assessment System Low Range Heparin Management Test Controls
- Applicant
- Cardiovascular Diagnostics, Inc.
Raleigh, NC, US - Received
- April 1, 1998
- Decision date
- April 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K161316 | George King Coumadin PlasmaGGN · Traditional | George King Bio-Medical, Inc. | 02/23/2017SE |
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| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | Cliniqa Corporation | 05/31/2013SE |
More from Cliniqa Corporation
| 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 |
| K981206 | Tas Results Data Acquisition System (Traqs)GKP · Traditional | 05/26/1998SE |
| 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 Thrombolytic Assessment System Low Range Heparin Management Test Controls cleared by the FDA?
Thrombolytic Assessment System Low Range Heparin Management Test Controls (K981178) received a 510(k) decision of Substantially Equivalent on April 27, 1998, 26 days after the submission was received.
What is the product code of K981178?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.