FDA Registration
Active
🇰🇷 South Korea
CELLTRAZONE CO., LTD
Reg #: 3013500651
·
FEI: 3013500651
·
Expires 2026
Products
4
Proprietary Names
21
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CELLTRAZONE CO., LTD
- Registration Number
- 3013500651
- FEI Number
- 3013500651
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1F, 6F, 16, ARAYUK-RO, GOCHON-EUP
- City
- GIMPO-SI Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Celltrazone Co., Ltd
- Operator Number
- 10053102
- Address
- 1F, 6F, 16, ARAYUK-RO, GOCHON-EUP
- City
- GIMPO-SI
- State
- Gyeonggi
- Postal Code
- 10136
- Country
- KR
- Correspondent
- SUN KI KIM
US Agent
- Business Name
- KMC USA, Inc
- Contact Name
- Jung Ryun Ahn
- Address
- 115 East 34th street, 13J
- City
- New York
- State
- NY
- ZIP
- 10016
- Country
- US
- [email protected]
- Phone
- 646 3576058
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Preservative, Cytological | LEA | Class 1 | Pathology | No | 2016-11-01 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2016-11-01 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2016-11-01 |
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2016-11-01 |
Proprietary Names
HURO PATH® Solution (Non-GYN)
HURO PATH® Solution (GYN)
HURO PATH® Solution (Body Fluid)
HURO PATH® Solution (SPUTUM)
HURO PATH® Lysis Solution (Hemolics)
HURO PATH® Solution (FNA) - BULK
HURO PATH® Solution (FNA)
HURO PATH® Solution (Diluent)
HURO PATH® Solution (Body Fluid) - BULK
HURO PATH® Solution (GYN) - BULK
HURO PATH® Solution (Urine)
HURO PATH® Solution (SPUTUM) - BULK
HURO PATH® Solution (Urine) - BULK
HURO PATH® Solution (Non-GYN) - BULK
HURO PATH® Lysis Solution (Contro-reagent)
Microscope slide (Adhesive)
HURO PATH® S
HURO PATH® T
HURO PATH® Filter
HURO PATH® V
HURO PATH® Filter (FNA)
Establishment Types
Manufacture Medical Device