FDA Registration
Active
🇺🇸 United States
Stat Profile pHOx Plus L
Reg #: 1219029
·
FEI: 1219029
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
3
Classifications
11
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
- K023567
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 |
|---|---|---|---|---|---|
| Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | JKS | Class 1 | Clinical Toxicology | No | 2015-01-12 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2015-01-12 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2015-01-12 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2015-01-12 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2015-01-12 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2015-01-12 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2015-01-12 |
| Test, Time, Prothrombin | GJS | Class 2 | Hematology | No | 2015-01-12 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2015-01-12 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2015-01-12 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2015-01-12 |
Proprietary Names
Stat Profile pHOx Plus L
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device
Manufacture Medical Device