Vital Scientific PT with Calcium
FDA 510(k) K020840 · Vital Scientific N.V.
510(k) numberK020840
Submission
- Device name
- Vital Scientific PT with Calcium
- Applicant
- Vital Scientific N.V.
Newton, MA, US - Received
- March 15, 2002
- Decision date
- May 15, 2002
- 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
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 |
|---|---|---|
| K022021 | Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional | 11/01/2002SE |
| K021976 | FIBRON-1, FIBRON-4, Quikcoag, FibronKQG · Traditional | 10/25/2002SE |
| K022046 | Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,QUIKCOAG…GGN · Traditional | 07/23/2002SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | 03/13/1998SE |
Questions and answers
When was Vital Scientific PT with Calcium cleared by the FDA?
Vital Scientific PT with Calcium (K020840) received a 510(k) decision of Substantially Equivalent on May 15, 2002, 61 days after the submission was received.
What is the product code of K020840?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.