FDA Registration
Active
🇺🇸 United States
SPOT HEALTH INC.
Reg #: 3026940910
·
FEI: 3026940910
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SPOT HEALTH INC.
- Registration Number
- 3026940910
- FEI Number
- 3026940910
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1776 Mentor Ave.
- City
- Cincinnati
- State
- OH
- ZIP
- 45212
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173887
Owner / Operator
- Firm Name
- Spot Health Inc.
- Operator Number
- 10089149
- Address
- 1776 Mentor Ave.
- City
- Cincinnati
- State
- OH
- Postal Code
- 45212
- Country
- US
- Correspondent
- Andrew Jajack
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2023-11-09 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-11-09 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-11-09 |
Establishment Types
Repack or Relabel Medical Device