FDA Registration
Active
🇺🇸 United States
RapidPoint 350
Reg #: 1220972
·
FEI: 1220972
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDICA CORP.
- Registration Number
- 1220972
- FEI Number
- 1220972
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 OAK PARK DRIVE
- City
- BEDFORD
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063376
Owner / Operator
- Firm Name
- MEDICA CORP.
- Operator Number
- 1220972
- Address
- 5 OAK PARK DRIVE, --
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- Photios E Makris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 1992-07-06 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 1992-07-06 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 1992-07-06 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 1992-07-06 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 1992-07-06 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 1992-07-06 |
Proprietary Names
RapidPoint 350
EASYSTAT
Establishment Types
Manufacture Medical Device