FDA device listing
SMARTLYTE® Electrolyte Analyzer
FDA device listing 1179639257 · Diamond Diagnostics Inc.
Key facts
| Proprietary names | SMARTLYTE® Electrolyte Analyzer |
|---|---|
| Owner/operator | Diamond Diagnostics Inc. |
| Owner/operator number | 10028706 |
| Premarket submissions | K121040 |
| Product codes | CEM, CGZ, JFP, JGS, JIH |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGZ - Electrode, Ion-Specific, Chloride, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, JIH - Flame Photometry, Lithium |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1145, 862.1170, 862.1600, 862.1665, 862.3560 |
| Review panels | Clinical Chemistry, Clinical Toxicology |
| Registered establishments | Diamond Diagnostics Inc., DIAMOND DIAGNOSTICS Inc |
| Establishment registrations | 3003030793, 3006198300 |
| FEI numbers | 3003030793, 3006198300 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database