FDA Registration
Active
🇺🇸 United States
Pylo Health Control Solution GL1-CTR
Reg #: 3017500903
·
FEI: 3017500903
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PREVOUNCE HEALTH, INC
- Registration Number
- 3017500903
- FEI Number
- 3017500903
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3250 N Post Road, STE 180
- City
- Indianapolis
- State
- IN
- ZIP
- 46226
- Country
- US
Owner / Operator
- Firm Name
- Prevounce Health, Inc
- Operator Number
- 10078004
- Address
- 3250, STE 180
- City
- Indianapolis
- State
- IN
- Postal Code
- 46226
- Country
- US
- Correspondent
- Daniel Tashnek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-01-03 |
Proprietary Names
Pylo Health Control Solution GL1-CTR
Establishment Types
Complaint File Establishment per 21 CFR 820.198