FDA Registration
Active
🇺🇸 United States
STATCUP II
Reg #: 3008416529
·
FEI: 3008416529
·
Expires 2025
Products
10
Proprietary Names
2
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- MICRO DISTRIBUTING II, LTD.
- Registration Number
- 3008416529
- FEI Number
- 3008416529
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 620 Kennedy Ct
- City
- Belton
- State
- TX
- ZIP
- 76513
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122904
Owner / Operator
- Firm Name
- Micro Distributing II, Ltd.
- Operator Number
- 10051894
- Address
- 620 Kennedy Court
- City
- Belton
- State
- TX
- Postal Code
- 76513
- Country
- US
- Correspondent
- David Wilks
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-12-27 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2019-12-27 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2019-12-27 |
Proprietary Names
STATCUP II
STATDIP
Establishment Types
Complaint File Establishment per 21 CFR 820.198