FDA Registration
Active
🇺🇸 United States
Urinalysis Reagent Dipsticks - 1-11 parameters
Reg #: 3005360469
·
FEI: 3005670738
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- ACRO BIOTECH Inc.
- Registration Number
- 3005360469
- FEI Number
- 3005670738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4650 Arrow Hwy Suite D6
- City
- Montclair
- State
- CA
- ZIP
- 91763
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051526
Owner / Operator
- Firm Name
- Acro Biotech Inc.
- Operator Number
- 10043465
- Address
- 4650 Arrow Hwy Suite D6
- City
- Montclair
- State
- CA
- Postal Code
- 91763
- Country
- US
- Correspondent
- Joseph Fan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2013-03-21 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2013-03-21 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2013-03-21 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-03-21 |
Proprietary Names
Urinalysis Reagent Dipsticks - 1-11 parameters
Establishment Types
Repack or Relabel Medical Device