FDA device listing
Blood Gas
FDA device listing 1586164006 · Diamond Diagnostics Inc.
Key facts
| Proprietary names | Blood Gas |
|---|---|
| Owner/operator | Diamond Diagnostics Inc. |
| Owner/operator number | 10028706 |
| Premarket submissions | K080370 |
| Product codes | CEM, CGA, CGZ, CHL, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGA - Glucose Oxidase, Glucose, CGZ - Electrode, Ion-Specific, Chloride, CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, GHS - Assay, Carboxyhemoglobin, GKR - System, Hemoglobin, Automated, GLY - Oximeter To Measure Hemoglobin, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, JIX - Calibrator, Multi-Analyte Mixture, JJY - Multi-Analyte Controls, All Kinds (Assayed), JPI - Device, Hematocrit Measuring |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1120, 862.1145, 862.1150, 862.1170, 862.1345, 862.1600, 862.1660, 862.1665, 864.5620, 864.6400, 864.7425, 864.7500 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | Diamond Diagnostics Inc. |
| Establishment registrations | 3006198300 |
| FEI numbers | 3006198300 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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