Simplastin Excel
FDA 510(k) K864283 · Organon Teknika Corp.
510(k) numberK864283
Submission
- Device name
- Simplastin Excel
- Applicant
- Organon Teknika Corp.
Kensington, TX, US - Received
- October 30, 1986
- Decision date
- December 4, 1986
- 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 |
|---|---|---|
| K003104 | Bact/Alert CSRLJF · Traditional | 10/20/2000SE |
| K000492 | Mda D-DimerDAP · Traditional | 06/07/2000SE |
| K000378 | Bact/Alert MB Culture BottleMDB · Traditional | 03/02/2000SE |
| K994343 | Bact/Alert SVMDB · Traditional | 02/10/2000SE |
| K993423 | Bact/Alert SAMDB · Traditional | 12/15/1999SE |
| K993576 | Bact/Alert MP Process BottleMDB · Traditional | 12/14/1999SE |
| K993421 | Bact/Alert SNMDB · Traditional | 12/14/1999SE |
| K992432 | Bact/Alert FNMDB · Traditional | 09/24/1999SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | 09/15/1999SE |
| K992401 | Bact/Alert PFMDB · Traditional | 09/03/1999SE |
Questions and answers
When was Simplastin Excel cleared by the FDA?
Simplastin Excel (K864283) received a 510(k) decision of Substantially Equivalent on December 4, 1986, 35 days after the submission was received.
What is the product code of K864283?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.