FDA Registration
Active
🇺🇸 United States
HemoScreen Hematology Analizer
Reg #: 3017382712
·
FEI: 3017382712
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PIXCELL MEDICAL INC.
- Registration Number
- 3017382712
- FEI Number
- 3017382712
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 825 Delaware Avenue, Suite 304
- City
- Longmont
- State
- CO
- ZIP
- 80501
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240636
Owner / Operator
- Firm Name
- Pixcell Medical Inc.
- Operator Number
- 10083503
- Address
- 825 Delaware Avenue, Suite 304
- City
- Longmont
- State
- CO
- Postal Code
- 80501
- Country
- US
- Correspondent
- Scott Peairs
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2024-11-25 |
Proprietary Names
HemoScreen Hematology Analizer
Establishment Types
Complaint File Establishment per 21 CFR 820.198