FDA Registration
Active
🇺🇸 United States
SENDX MEDICAL, INC.
Reg #: 2027541
·
FEI: 2027541
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SENDX MEDICAL, INC.
- Registration Number
- 2027541
- FEI Number
- 2027541
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1945 PALOMAR OAKS WAY
- City
- CARLSBAD
- State
- CA
- ZIP
- 92011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051804
Owner / Operator
- Firm Name
- RADIOMETER MEDICAL APS
- Operator Number
- 8020503
- Address
- AAKANDEVEJ 21, --
- City
- BROENSHOEJ
- State
- Hovedstaden
- Postal Code
- 2700
- Country
- DK
- Correspondent
- Hsiao-Qing Chow
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2006-02-24 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2006-02-24 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2006-02-24 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2006-02-24 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2006-02-24 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2006-02-24 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2006-02-24 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2006-02-24 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2006-02-24 |
Establishment Types
Manufacture Medical Device