COAG-1 Pt-Nc Test Card
FDA 510(k) K904325 · Cardiovascular Diagnostic Services
510(k) numberK904325
Submission
- Device name
- COAG-1 Pt-Nc Test Card
- Applicant
- Cardiovascular Diagnostic Services
Research Triangle Park, NC, US - Received
- September 20, 1990
- Decision date
- January 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
Other 510(k)s with product code GJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253188 | CoaguChek XS Plus SystemGJS · Special | Roche Diagnostics | 10/24/2025SE |
| K251564 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 07/21/2025SE |
| K243543 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 02/27/2025SE |
| K230802 | Xprecia Prime Coagulation SystemGJS · Dual Track | Universal Biosensors Pty, Ltd. | 03/15/2024SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | Abbott Laboratories | 07/14/2023SE |
| K231711 | microINR SystemGJS · Special | Iline Microsystems, S.L. | 07/11/2023SE |
| K211485 | STA- NeoPTimalGJS · Traditional | Diagnostica Stago S.A.S | 12/23/2022SE |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special | Coagusense, Inc. | 10/05/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
| K201185 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 12/18/2020SE |
More from Iline Microsystems, S.L.
| 510(k) | Device | Decision |
|---|---|---|
| K955843 | Tas PtoneGJS · Traditional | 03/18/1996SE |
| K933092 | Tas AnalyzerGKP · Traditional | 11/15/1993SE |
| K903019 | Modified COAG-1 PT Test CardGJS · Traditional | 08/01/1990SE |
| K891015 | COAG-1 Aptt Test CardGFO · Traditional | 05/22/1989SE |
| K882456 | Coag-I PT Test CardGJS · Traditional | 08/25/1988SE |
| K882444 | Coag-I Analyzer, Alpha ModelJPA · Traditional | 08/25/1988SE |
| K812304 | Dorros-Spring PressurizerMAV · Traditional | 10/13/1981SE |
Questions and answers
When was COAG-1 Pt-Nc Test Card cleared by the FDA?
COAG-1 Pt-Nc Test Card (K904325) received a 510(k) decision of Substantially Equivalent on January 25, 1991, 127 days after the submission was received.
What is the product code of K904325?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.