FDA Registration
Active
🇺🇸 United States
Stat Profile Prime ES Comp Plus Analyzer System
Reg #: 1219029
·
FEI: 1219029
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
3
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
- K191365
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 |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2019-12-12 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2019-12-12 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2019-12-12 |
Proprietary Names
Stat Profile Prime ES Comp Plus Analyzer System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device
Manufacture Medical Device