FDA Registration
Active
🇺🇸 United States
Expanded Range High Sensitivity Salivary Cortisol Enzyme immunoassay Kit
Reg #: 3003760091
·
FEI: 3003760091
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SALIMETRICS LLC.
- Registration Number
- 3003760091
- FEI Number
- 3003760091
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 INNOVATION BLVD STE 302
- City
- State College
- State
- PA
- ZIP
- 16803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031348
Owner / Operator
- Firm Name
- SALIMETRICS LLC.
- Operator Number
- 9045886
- Address
- 101 INNOVATION BLVD., STE. 302, --
- City
- State College
- State
- PA
- Postal Code
- 16803
- Country
- US
- Correspondent
- Mark Hollerbach
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cortisol, Salivary | NHG | Class 2 | Clinical Chemistry | No | 2007-11-08 |
Proprietary Names
Expanded Range High Sensitivity Salivary Cortisol Enzyme immunoassay Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device