Tissue-Tek®
Scraper, Large
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | IEO |
| Device type | Processor, Tissue, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3875 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1550 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 25 |
| Thermo Fisher | Shandon Diagnostics Limited | 11 |
| HistoCore Peloris | Leica Biosystems Melbourne PTY Ltd | 9 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 3 |
| Tissue-Tek VIP® 6 | Sakura Finetek U.S.A., Inc. | 2 |
| PathTezt® | Biocytech Corporation SDN BHD | 2 |
| Tissue-Tek VIP® | Sakura Finetek U.S.A., Inc. | 2 |
| Basket | Leica Biosystems Nussloch Gmbh | 1 |
| Basket, assy., large | Leica Biosystems Nussloch Gmbh | 1 |
| Anybattery | Anybattery, Inc | 1 |
| Leica ASP300 S | Leica Biosystems Nussloch Gmbh | 1 |
| HistoPro® | Rushabh Instruments, LLC | 1 |
Showing 12 of 52. All products under Processor, Tissue, Automated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881165 | 1988-07-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.