FDA Registration
Active
🇺🇸 United States
NOVA BIOMEDICAL CORPORATION
Reg #: 1219029
·
FEI: 1219029
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NOVA BIOMEDICAL CORPORATION
- Registration Number
- 1219029
- FEI Number
- 1219029
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200 Prospect St
- City
- WALTHAM
- State
- MA
- ZIP
- 02454
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122688
Owner / Operator
- Firm Name
- NOVA BIOMEDICAL CORP.
- Operator Number
- 1219029
- Address
- 200 PROSPECT ST., --
- City
- Waltham
- State
- MA
- Postal Code
- 02454
- Country
- US
- Correspondent
- John F McHale
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-07-17 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-07-17 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2013-07-17 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2013-07-17 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device