Sodium
FDA 510(k) K771839 · Gamma Enterprises, Inc.
510(k) numberK771839
Submission
- Device name
- Sodium
- Applicant
- Gamma Enterprises, Inc.
Mchenry, IL, US - Received
- September 21, 1977
- Decision date
- November 2, 1977
- 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
Other 510(k)s with product code JGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| 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 |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K790578 | Gamma Smac ReagentsCIG · Traditional | 05/15/1979SE |
| K780507 | Serum Glutamic-Pyruvic TransaminaseCKC · Traditional | 05/03/1978SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | 05/03/1978SE |
| K780505 | Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional | 05/03/1978SE |
| K780504 | Creatine Phosphokinase (CPK)JHS · Traditional | 05/03/1978SE |
| K771843 | Wetting Agents · Traditional | 11/22/1977SE |
| K771836 | Lactate DehydrogenaseCFJ · Traditional | 11/22/1977SE |
| K771832 | ChlorideJFS · Traditional | 11/22/1977SE |
| K771838 | Serum IronJIY · Traditional | 11/03/1977SE |
| K771834 | CreatinineCGX · Traditional | 11/03/1977SE |
Questions and answers
When was Sodium cleared by the FDA?
Sodium (K771839) received a 510(k) decision of Substantially Equivalent on November 2, 1977, 42 days after the submission was received.
What is the product code of K771839?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.