Data / Medical devices / Apparatus, Cell-Freezing And Reagents
Apparatus, Cell-Freezing And Reagents (KSP): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Apparatus, Cell-Freezing And Reagents (product code KSP, Class 1, 21 CFR 864.9225). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 21, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSP
- Device class
- 1
- Regulation
- 864.9225
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| China | 2 |
| United Kingdom | 1 |
Makers of Apparatus, Cell-Freezing And Reagents
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mve Biological Solutions Us LLC | New Prague, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd | Pidu District Chengdu Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phasetwo, A Division Of Tomco2 Systems Company | Alpharetta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PLANER Limited | SUNBURY, MIDDLESEX England, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhein Laser Technologies Co., Ltd. | wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 21, 1988. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.