FDA Registration
Active
🇺🇸 United States
Optical Density Step Tablet
Reg #: 1644474
·
FEI: 1000116989
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HELENA LABORATORIES, CORP.
- Registration Number
- 1644474
- FEI Number
- 1000116989
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3795 WASHINGTON BLVD.
- City
- BEAUMONT
- State
- TX
- ZIP
- 77705
- Country
- US
Owner / Operator
- Firm Name
- HELENA LABORATORIES, CORP.
- Operator Number
- 1618982
- Address
- 1530 LINDBERGH DRIVE
- City
- Beaumont
- State
- TX
- Postal Code
- 77707
- Country
- US
- Correspondent
- Rachel Easley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Densitometeric, Protein Fractionation | JQJ | Class 1 | Clinical Chemistry | No | 2012-10-25 |
Proprietary Names
Optical Density Step Tablet
Neutral Density Densitometer Control for QuickScan
DZA Replacement Lamp for REP
Neutral Density Densitometer Control SPIFE Nexus
Neutral Density Densitometer Control SPIFE 4000
Establishment Types
Manufacture Medical Device