FDA Registration
Active
🇺🇸 United States
ClearRapids
Reg #: 1063851
·
FEI: 1000442352
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- MERCEDES MEDICAL LLC
- Registration Number
- 1063851
- FEI Number
- 1000442352
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12210 Rangeland Parkway
- City
- Lakewood Ranch
- State
- FL
- ZIP
- 34211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131811
Owner / Operator
- Firm Name
- MERCEDES MEDICAL LLC
- Operator Number
- 9033351
- Address
- 12210 Rangeland Parkway, --
- City
- Lakewood Ranch
- State
- FL
- Postal Code
- 34211
- Country
- US
- Correspondent
- Misty - McWhorter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-11-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-11-27 |
Proprietary Names
ClearRapids
Establishment Types
Complaint File Establishment per 21 CFR 820.198