Sodium Electrode Rinse Solution 2
FDA 510(k) K841418 · Reagent Laboratory, Inc.
510(k) numberK841418
Submission
- Device name
- Sodium Electrode Rinse Solution 2
- Applicant
- Reagent Laboratory, Inc.
Mchenry, IL, US - Received
- April 5, 1984
- Decision date
- May 16, 1984
- 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 |
|---|---|---|
| K863502 | Solution B- Na 50MEQ/L, K 40 Meq/LJIX · Traditional | 10/21/1986SE |
| K863503 | HemolyseGGK · Traditional | 10/03/1986SE |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | 10/02/1986SE |
| K860143 | Urine Diluent-For Use with Ion Selective ElectrodeJJP · Traditional | 02/10/1986SE |
| K842982 | Formalin BufferedIFP · Traditional | 10/01/1984SE |
| K843050 | Gram StainJTS · Traditional | 09/11/1984SE |
| K842785 | Stain, Methylene Blue-EosinKFC · Traditional | 09/11/1984SE |
| K841847 | Lithium ReagentJJO · Traditional | 08/17/1984SE |
| K843051 | Wrights Stain Solution · Traditional | 08/03/1984SESP |
| K841800 | Lysing & Hemoglobin ReagentGGK · Traditional | 05/31/1984SE |
Questions and answers
When was Sodium Electrode Rinse Solution 2 cleared by the FDA?
Sodium Electrode Rinse Solution 2 (K841418) received a 510(k) decision of Substantially Equivalent on May 16, 1984, 41 days after the submission was received.
What is the product code of K841418?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.