Ref. Membrane for Orion 1020 Sodium/Potassium Ana.
FDA 510(k) K864862 · Hf Scientific, Inc.
510(k) numberK864862
Submission
- Device name
- Ref. Membrane for Orion 1020 Sodium/Potassium Ana.
- Applicant
- Hf Scientific, Inc.
Ft. Myers, FL, US - Received
- December 11, 1986
- Decision date
- February 20, 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 |
|---|---|---|
| K882801 | Rinse & Reference Solution/Buffer/Low & High Stan.JGS · Traditional | 08/29/1988SE |
| K880967 | Micro CO2 ApparatusCIE · Traditional | 04/28/1988SE |
| K874429 | Hemoglobin Determination Test Kit HGB S-100 & 12GIQ · Traditional | 02/04/1988SE |
| K864313 | CO2 Reagent SetCIE · Traditional | 03/13/1987SE |
Questions and answers
When was Ref. Membrane for Orion 1020 Sodium/Potassium Ana. cleared by the FDA?
Ref. Membrane for Orion 1020 Sodium/Potassium Ana. (K864862) received a 510(k) decision of Substantially Equivalent on February 20, 1987, 71 days after the submission was received.
What is the product code of K864862?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.