Dia Thrombin Dia Plastin
FDA 510(k) K840802 · Diatech, Inc.
510(k) numberK840802
Submission
- Device name
- Dia Thrombin Dia Plastin
- Applicant
- Diatech, Inc.
Mchenry, IL, US - Received
- February 23, 1984
- Decision date
- May 1, 1984
- 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 |
|---|---|---|
| K881685 | Fibrinogentest-OGIS · Traditional | 08/09/1988SE |
| K854938 | Coascreener/Diascreenerblood Plasma Timing Inst.JPA · Traditional | 03/12/1986SE |
| K854090 | DIATIMER-2 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K854089 | DIATIMER-1 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K842286 | Dia T1, T2 & T3JPK · Traditional | 09/11/1984SE |
| K841523 | Owren's Veronal BufferrJPA · Traditional | 06/01/1984SE |
| K841462 | Heparin Coagulation Control Plasma 1-JPA · Traditional | 06/01/1984SE |
| K841366 | Dia FibrinKQJ · Traditional | 06/01/1984SE |
| K841365 | Dia ReptinGIR · Traditional | 06/01/1984SE |
| K841461 | Coagulation Control Plasma Level 1/2/3GGP · Traditional | 05/02/1984SE |
Questions and answers
When was Dia Thrombin Dia Plastin cleared by the FDA?
Dia Thrombin Dia Plastin (K840802) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 68 days after the submission was received.
What is the product code of K840802?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.