Ionometer Ef-Hk and Accessories
FDA 510(k) K901042 · Fresenius USA, Inc.
510(k) numberK901042
Submission
- Device name
- Ionometer Ef-Hk and Accessories
- Applicant
- Fresenius USA, Inc.
Concord, CA, US - Received
- March 6, 1990
- Decision date
- July 31, 1990
- 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 |
|---|---|---|
| K992275 | Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…KDI · Special | 08/04/1999SE |
| K970700 | Fresenius Polysulfone Hemodialyzers, Both Low and High FluxMSE · Traditional | 09/15/1998SE |
| K974584 | Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSKDI · Traditional | 05/14/1998SE |
| K973378 | C.A.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model…CAC · Traditional | 11/03/1997SE |
| K961465 | 2008H on Line Clearance MonitorKDI · Traditional | 07/03/1997SE |
| K961706 | P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorLKN · Traditional | 07/31/1996SE |
| K955762 | Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramKPF · Traditional | 07/31/1996SE |
| K941460 | Fresenius Blood Temperature MonitorMQS · Traditional | 07/03/1996SE |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | 06/13/1996SE |
| K944767 | Dialysis Machine with Dialysate UltrafilterFIP · Traditional | 11/29/1995SE |
Questions and answers
When was Ionometer Ef-Hk and Accessories cleared by the FDA?
Ionometer Ef-Hk and Accessories (K901042) received a 510(k) decision of Substantially Equivalent on July 31, 1990, 147 days after the submission was received.
What is the product code of K901042?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.