FDA Registration
Active
🇺🇸 United States
476846 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 400)
Reg #: 2050012
·
FEI: 2050012
·
Expires 2025
Products
5
Proprietary Names
4
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050012
- FEI Number
- 2050012
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 250 S Kraemer Blvd
- City
- BREA
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971333
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2010-08-31 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2010-08-31 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2010-08-31 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2010-08-31 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2010-08-31 |
Proprietary Names
476846 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 400)
442670 Alkaline Phosphatase Reagent (ALP 2 x 200)
442650 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 200)
476821 Alkaline Phosphatase Reagent (ALP 2 x 400)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility