FDA Registration
Active
🇺🇸 United States
Synermed IR500 Chemistry Analyzer IVD
Reg #: 3003593973
·
FEI: 3003593973
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Infrared Laboratory Systems dba SYNERMED
- Registration Number
- 3003593973
- FEI Number
- 3003593973
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17408 Tiller Ct Ste 1900
- City
- WESTFIELD
- State
- IN
- ZIP
- 46074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K935662
Owner / Operator
- Firm Name
- Infrared Laboratory Systems, LLC
- Operator Number
- 10038715
- Address
- 17408 Tiller Court Suite 1900
- City
- Westfield
- State
- IN
- Postal Code
- 46074
- Country
- US
- Correspondent
- Craig L Denney
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2011-11-04 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2011-11-04 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2011-11-04 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2011-11-04 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2011-11-04 |
Proprietary Names
Synermed IR500 Chemistry Analyzer IVD
Establishment Types
Manufacture Medical Device