Dart (R) Electrolyte Reagent System
FDA 510(k) K874185 · Coulter Electronics, Inc.
510(k) numberK874185
Submission
- Device name
- Dart (R) Electrolyte Reagent System
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- October 14, 1987
- Decision date
- November 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
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| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
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| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
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| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Dart (R) Electrolyte Reagent System cleared by the FDA?
Dart (R) Electrolyte Reagent System (K874185) received a 510(k) decision of Substantially Equivalent on November 4, 1987, 21 days after the submission was received.
What is the product code of K874185?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.