JGM
5 FDA 510(k) clearances · Product code
29 daysmedian time to decision
88 days90th percentile
5clearances measured
FDA profile
- Official device name
- Flame Photometry, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER (K895718) | Data Medical Associates, Inc. | 1989-10-19 |
| AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT (K862300) | Amresco, Inc. | 1986-07-29 |
| MSI-NAK-50 TEST KIT (K831300) | Medical Specialties, Inc. | 1983-07-18 |
| SODIUM & POTASSIUM TEST KIT (K810253) | Mallinckrodt Critical Care | 1981-02-10 |
| TRIGLYCERIDE KIT (K771068) | Environmental Chemical Specialties | 1977-07-12 |
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Every clearance here is in the API, with alerts when new ones post.