FDA Registration
Active
🇭🇰 Hong Kong
Fourstar Group
Reg #: 3007838093
·
FEI: 3007838093
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Fourstar Group
- Registration Number
- 3007838093
- FEI Number
- 3007838093
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 41 Main Yue St, Unit A, 8/F, Kaiser Estate Phase 1, Kowloon
- City
- Kowloon
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K153597
Owner / Operator
- Firm Name
- FOURSTAR GROUP INC.
- Operator Number
- 8043323
- Address
- L101 Teva Cultural & Creative Plaza, No. 1010, Qiao Xiang Road, Futian District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518034
- Country
- CN
- Correspondent
- Ted Conlon
US Agent
- Business Name
- Fourstar Group USA, Inc.
- Contact Name
- Edward Conlon
- Address
- 189 Main St Ste 31
- City
- Milford
- State
- MA
- ZIP
- 01757
- Country
- US
- [email protected]
- Phone
- 508 4737388 ext. 2004
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-04-07 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-04-07 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device