Hemosil Recombiplastin 2G (8 ML Vial)
FDA 510(k) K132722 · Instrumentation Laboratory CO
510(k) numberK132722
Submission
- Device name
- Hemosil Recombiplastin 2G (8 ML Vial)
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- August 30, 2013
- Decision date
- January 22, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Hemosil Recombiplastin 2G (8 ML Vial) cleared by the FDA?
Hemosil Recombiplastin 2G (8 ML Vial) (K132722) received a 510(k) decision of Substantially Equivalent on January 22, 2014, 145 days after the submission was received.
What is the product code of K132722?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.