Prothrombin Time Test Card
FDA 510(k) K954625 · Cardiovascular Diagnostics, Inc.
510(k) numberK954625
Submission
- Device name
- Prothrombin Time Test Card
- Applicant
- Cardiovascular Diagnostics, Inc.
Raleigh, NC, US - Received
- September 27, 1995
- Decision date
- March 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
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|---|---|---|
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| 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 |
Questions and answers
When was Prothrombin Time Test Card cleared by the FDA?
Prothrombin Time Test Card (K954625) received a 510(k) decision of Substantially Equivalent on March 11, 1996, 166 days after the submission was received.
What is the product code of K954625?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.