Dade Thromboplastin Is
FDA 510(k) K891169 · Baxter Healthcare Corp
510(k) numberK891169
Submission
- Device name
- Dade Thromboplastin Is
- Applicant
- Baxter Healthcare Corp
Miami, FL, US - Received
- March 6, 1989
- Decision date
- April 10, 1989
- 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 |
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| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
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| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Dade Thromboplastin Is cleared by the FDA?
Dade Thromboplastin Is (K891169) received a 510(k) decision of Substantially Equivalent on April 10, 1989, 35 days after the submission was received.
What is the product code of K891169?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.