FDA Registration
Active
🇺🇸 United States
OPTI R
Reg #: 3004102403
·
FEI: 3004102403
·
Expires 2025
Products
7
Proprietary Names
2
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- OPTI MEDICAL SYSTEMS INC.
- Registration Number
- 3004102403
- FEI Number
- 3004102403
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 235 Hembree Park Dr
- City
- ROSWELL
- State
- GA
- ZIP
- 30076
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061730
Owner / Operator
- Firm Name
- IDEXX LABORATORIES INC.
- Operator Number
- 9097732
- Address
- ONE IDEXX DR., --
- City
- Westbrook
- State
- ME
- Postal Code
- 04092
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2007-12-08 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2007-12-08 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2007-12-08 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2007-12-08 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2007-12-08 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2007-12-08 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2007-12-08 |
Proprietary Names
OPTI R
OPTI R Analyzer
Establishment Types
Manufacture Medical Device