FDA Registration
Active
🇺🇸 United States
Nova Max Plus
Reg #: 1219029
·
FEI: 1219029
·
Expires 2025
Products
4
Proprietary Names
1
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
- K091547
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 |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2010-11-26 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2010-11-26 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2010-11-26 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2010-11-26 |
Proprietary Names
Nova Max Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device