JID
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Photometric Method, Ammonia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1065
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2015: 40 · 2016: 10 · 2019: 13 · 2020: 26 · 2021: 19 · 2023: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| CARESIDE AMMONIA (K991371) | Careside, Inc. | 1999-08-03 | + Add |
| KODAK EKTACHEM CLINICAL CHEM. NH3 (K820723) | Eastman Kodak Company | 1982-04-01 | + Add |
| AMMONIA TEST (K813366) | Wako Pure Chemical Industries, Ltd. | 1981-12-22 | + Add |
Track JID automatically
Every clearance here is in the API, with alerts when new ones post.