Genchem Ise Electrolyte Reference
FDA 510(k) K040971 · Genchem, Inc.
510(k) numberK040971
Submission
- Device name
- Genchem Ise Electrolyte Reference
- Applicant
- Genchem, Inc.
Brea, CA, US - Received
- April 14, 2004
- Decision date
- December 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K090283 | Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3JIX · Abbreviated | 06/05/2009SE |
| K040977 | Genchem Electrolyte BufferJGS · Traditional | 12/27/2004SE |
| K040976 | Genchem Creatinine ReagentCGX · Traditional | 12/27/2004SE |
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | 12/27/2004SE |
| K040974 | Glucose Oxidase, GlucoseCGA · Traditional | 12/27/2004SE |
| K040973 | Bun ReagentCDS · Traditional | 12/27/2004SE |
| K040972 | Calcium, Azo Dye ReagentCJY · Traditional | 12/27/2004SE |
Questions and answers
When was Genchem Ise Electrolyte Reference cleared by the FDA?
Genchem Ise Electrolyte Reference (K040971) received a 510(k) decision of Substantially Equivalent on December 22, 2004, 252 days after the submission was received.
What is the product code of K040971?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.