Sodium/Potassium Reagent Kit
FDA 510(k) K873126 · A-Kem, Inc.
510(k) numberK873126
Submission
- Device name
- Sodium/Potassium Reagent Kit
- Applicant
- A-Kem, Inc.
Clifton, NJ, US - Received
- August 10, 1987
- Decision date
- October 23, 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
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 |
|---|---|---|
| K884224 | Total Bilirubin Reagent Kit for Astra SystemsCIG · Traditional | 12/15/1988SE |
| K884227 | Calibrator Standard Kit for Astra SystemJIX · Traditional | 12/09/1988SE |
| K884226 | Amylase Reagent Kit for Astra SystemsCJA · Traditional | 12/09/1988SE |
| K884225 | Total Protein Reagent Kit for Astra SystemsCEK · Traditional | 12/09/1988SE |
| K882587 | A-Kem Albumin Reagent Kit for Astra SystemCIX · Traditional | 08/08/1988SE |
| K882586 | A-Kem Calcium Reagent Kit for Astra SystemCIC · Traditional | 08/08/1988SE |
| K873132 | Bun Reagent KitLFP · Traditional | 10/23/1987SE |
| K873131 | Creatinine Reagent KitCGX · Traditional | 10/23/1987SE |
| K873130 | Wash Solution KitJJE · Traditional | 10/23/1987SE |
| K873129 | Carbon Dioxide Reagent KitJFL · Traditional | 10/23/1987SE |
Questions and answers
When was Sodium/Potassium Reagent Kit cleared by the FDA?
Sodium/Potassium Reagent Kit (K873126) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 74 days after the submission was received.
What is the product code of K873126?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.