FDA Registration
Active
🇺🇸 United States
LABCON, NORTH AMERICA
Reg #: 2916657
·
FEI: 2916657
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- LABCON, NORTH AMERICA
- Registration Number
- 2916657
- FEI Number
- 2916657
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3700 LAKEVILLE HWY., STE. 200
- City
- PETALUMA
- State
- CA
- ZIP
- 94954
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2012-12-19 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2012-12-19 |
| Pipette, Quantitative, Hematology | GJG | Class 1 | Hematology | No | 2013-01-22 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2012-12-19 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2012-12-19 |
Proprietary Names
SuperClear Culture Tube
Urine Tube
SuperClear Mailing Tube
SuperClear Sample Vial
Urine Time II
P-Splitter
H-Pette
H-Pette with Blade
H-Pette II
H-Pette without Blade
C-Pette
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device