FDA Registration
Active
🇺🇸 United States
Tissue-Tek® Uni-Cassette® Stacked Cassettes
Reg #: 2083544
·
FEI: 2083544
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SAKURA FINETEK U.S.A., INC.
- Registration Number
- 2083544
- FEI Number
- 2083544
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1750 W 214th St
- City
- TORRANCE
- State
- CA
- ZIP
- 90501
- Country
- US
Owner / Operator
- Firm Name
- Sakura Global Holding Company
- Operator Number
- 8031662
- Address
- 1750 W 214th St
- City
- Torrance
- State
- CA
- Postal Code
- 90501
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 1995-02-03 |
Proprietary Names
Tissue-Tek® Uni-Cassette® Stacked Cassettes
Tissue-Tek® Uni-Cassette® Biopsy Cassette System
Tissue-Tek® Paraform® Sectionable Cassette System
Tissue-Tek® Processing/Embedding Cassette System
Tissue-Tek® Uni-Cassette® Standard Cassette System
Histo-Tek® Standard and Biopsy Cassette System
Tissue-Tek® Paraform® LP Stacked Frames
Tissue-Tek® Paraform® Tissue Orientation Gels
Tissue-Tek® Mega-Cassette System
Tissue-Tek® Paraform® Tubed Frames
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device