FDA Registration
Active
🇺🇸 United States
Femlab Vaginitis Test Kit
Reg #: 3025672
·
FEI: 1000126037
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- AMERITEK USA, INC.
- Registration Number
- 3025672
- FEI Number
- 1000126037
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 125 130th St SE Ste 200
- City
- EVERETT
- State
- WA
- ZIP
- 98208
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050352
Owner / Operator
- Firm Name
- AMERITEK USA, INC.
- Operator Number
- 9002732
- Address
- 125 130 TH STREET SE, --
- City
- Everett
- State
- WA
- Postal Code
- 98208
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2008-05-11 |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | Class 1 | Microbiology | No | 2008-05-11 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2008-05-11 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2008-05-11 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2008-05-11 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2008-05-11 |
Proprietary Names
Femlab Vaginitis Test Kit
Establishment Types
Manufacture Medical Device