CLP Prothrombin Time Test
FDA 510(k) K880566 · Creative Laboratory Products, Inc.
510(k) numberK880566
Submission
- Device name
- CLP Prothrombin Time Test
- Applicant
- Creative Laboratory Products, Inc.
Indianapolis, IN, US - Received
- February 10, 1988
- Decision date
- March 23, 1988
- 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
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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 |
More from Iline Microsystems, S.L.
| 510(k) | Device | Decision |
|---|---|---|
| K950589 | CLP High Level High Density Lipo Protein Cholesterol Control-HlJJX · Traditional | 03/20/1995SE |
| K942284 | CLP Total Iron and Uibc/Tibc Linearity Control SetJJX · Traditional | 08/26/1994SE |
| K922995 | Lipid ControlsJJX · Traditional | 08/12/1992SE |
| K913427 | Sickle Hemoglobin (Hba/S) Control SetJCM · Traditional | 11/19/1991SE |
| K913371 | Total Iron and Unsat Iron Bind Capac/Iron Bind CalJIT · Traditional | 11/08/1991SE |
| K913585 | Lipase Linearity ControlJJX · Traditional | 10/21/1991SE |
| K913224 | Lipid Linearity ControlsJJY · Traditional | 09/25/1991SE |
| K913496 | Cholinesterase Linearity ControlJJX · Traditional | 09/11/1991SE |
| K912823 | High Density Lipoprotein CholesterolLBR · Traditional | 08/16/1991SE |
| K912725 | Total Iron & Unsat Iron Bind Cap/Iron Bind ControlJJY · Traditional | 07/30/1991SE |
Questions and answers
When was CLP Prothrombin Time Test cleared by the FDA?
CLP Prothrombin Time Test (K880566) received a 510(k) decision of Substantially Equivalent on March 23, 1988, 42 days after the submission was received.
What is the product code of K880566?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.