FDA Registration
Active
🇺🇸 United States
accesa Cholesterol Panel
Reg #: 1423455
·
FEI: 3000206414
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HOME ACCESS HEALTH CORP.
- Registration Number
- 1423455
- FEI Number
- 3000206414
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2401 Hassell Rd Ste 1510
- City
- Hoffman Est
- State
- IL
- ZIP
- 60169
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063852
Owner / Operator
- Firm Name
- PWNHealth Chicago, LLC
- Operator Number
- 9031348
- Address
- 2401 W. HASSELL RD., SUITE 1510
- City
- Hoffman Estates
- State
- IL
- Postal Code
- 60169
- Country
- US
- Correspondent
- nikolas isely
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2007-11-26 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2007-11-26 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2007-11-26 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2007-11-26 |
Proprietary Names
accesa Cholesterol Panel
Establishment Types
Manufacture Medical Device