Acticlot, Model 824
FDA 510(k) K052124 · American Diagnostica, Inc.
510(k) numberK052124
Submission
- Device name
- Acticlot, Model 824
- Applicant
- American Diagnostica, Inc.
Stamford, CT, US - Received
- August 5, 2005
- Decision date
- October 17, 2005
- 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
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|---|---|---|---|
| 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 |
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| K013168 | Imubind Plasma PAI-1 Elisa,Model 822GGP · Traditional | 03/07/2002SE |
| K012386 | Acticlot Protein S, Model 843LGGP · Traditional | 09/14/2001SE |
| K940490 | DV Test and DVV ConfirmGIR · Traditional | 04/05/1995SE |
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Questions and answers
When was Acticlot, Model 824 cleared by the FDA?
Acticlot, Model 824 (K052124) received a 510(k) decision of Substantially Equivalent on October 17, 2005, 73 days after the submission was received.
What is the product code of K052124?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.