FDA Registration
Active
🇺🇸 United States
EtOH urine, EasyRA assay
Reg #: 1220972
·
FEI: 1220972
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K111005
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 |
|---|---|---|---|---|---|
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2012-02-14 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2012-02-14 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2012-02-14 |
Proprietary Names
EtOH urine, EasyRA assay
Establishment Types
Manufacture Medical Device