FDA Registration
Active
🇺🇸 United States
iChemVELOCITY Automated Urine Chemistry System (800-7167)
Reg #: 2122870
·
FEI: 2122870
·
Expires 2025
Products
12
Proprietary Names
7
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2122870
- FEI Number
- 2122870
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1000 LAKE HAZELTINE DR.
- City
- CHASKA
- State
- MN
- ZIP
- 55318
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101852
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- David G Davis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2014-08-18 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2014-08-18 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2014-08-18 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2014-08-18 |
Proprietary Names
iChemVELOCITY Automated Urine Chemistry System (800-7167)
Back-Integrated iChemVELOCITY (800-7720)
Stand-Alone iChemVELOCITY (800-7719)
iChemVELOCITY Computerless (800-3530)
iChemVELOCITY Automated Urine Chemistry System w load/unload (800-7166)
UA Win10 Kit (C52900)
iChemVELOCITY Urine Chemistry Strips (800-7212)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)