FDA Registration
Active
🇨🇳 China
Mission U500 Urine Analyzer
Reg #: 9615507
·
FEI: 3002829675
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- ACON BIOTECH (HANGZHOU) CO., LTD.
- Registration Number
- 9615507
- FEI Number
- 3002829675
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 210 Zhenzhong Road, West Lake District
- City
- HANGZHOU Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K111221
Owner / Operator
- Firm Name
- ACON Laboratories Inc.
- Operator Number
- 9033096
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Catherine Shi
US Agent
- Business Name
- ACON LABORATORIES INC.
- Contact Name
- Catherine Shi
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 858 8758068
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2012-04-02 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2012-04-02 |
| Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | NGJ | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2012-04-02 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2012-04-02 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2012-04-02 |
Proprietary Names
Mission U500 Urine Analyzer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)