FDA device listing
Histo-Tek Mini Stainer,Histo-Tek SL,TISSUE-TEK DRS 2000 A,Tissue-Tek Genie® Advanced Stainer, and Accessories,Tissue-Tek…
FDA device listing 1637224832 · Sakura Global Holding Company
Key facts
| Proprietary names | Histo-Tek Mini Stainer,Histo-Tek SL,TISSUE-TEK DRS 2000 A,Tissue-Tek Genie® Advanced Stainer, and Accessories,Tissue-Tek Prisma Automated Stainer,Tissue-Tek Prisma Plus Automated Slide Stainer |
|---|---|
| Owner/operator | Sakura Global Holding Company |
| Owner/operator number | 8031662 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | SAKURA FINETEK JAPAN CO., LTD, SAKURA FINETEK U.S.A., INC., SAKURA SEIKI CO., LTD. |
| Establishment registrations | 2083544, 9680927, 1000303355 |
| FEI numbers | 2083544, 1000303355, 3007419242 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database