Flame Photometry, Potassium
Flame Photometry for Potassium is a clinical chemistry test system employing flame photometric detection to measure potassium ion concentration in blood or serum, supporting assessment of electrolyte balance, cardiac function, and renal status. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and general and special controls compliance. The product code is JGM, regulated under 21 CFR 862.1600, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
Research product code JGM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JGM
- Device Class
- FDA class 2
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K895718 | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER | Oct 19, 1989 | Substantially Equivalent | Data Medical Associates, Inc. |
| K862300 | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT | Jul 29, 1986 | Substantially Equivalent | Amresco, Inc. |
| K831300 | MSI-NAK-50 TEST KIT | Jul 18, 1983 | Substantially Equivalent | Medical Specialties, Inc. |
| K810253 | SODIUM & POTASSIUM TEST KIT | Feb 10, 1981 | Substantially Equivalent | Mallinckrodt Critical Care |
| K771068 | TRIGLYCERIDE KIT | Jul 12, 1977 | Substantially Equivalent | Environmental Chemical Specialties |