FDA Registration
Active
🇺🇸 United States
Clinitek Novus Calibrator Kit
Reg #: 1181121
·
FEI: 1181121
·
Expires 2025
Products
12
Proprietary Names
2
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Fisher Diagnostics
- Registration Number
- 1181121
- FEI Number
- 1181121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8365 VALLEY PIKE
- City
- MIDDLETOWN
- State
- VA
- ZIP
- 22645
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140717
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2015-01-06 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2015-01-06 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2015-01-06 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2015-01-06 |
Proprietary Names
Clinitek Novus Calibrator Kit
Clinitek Novus Rinse Additive Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)