Data / Medical devices / Chamber, Slide Culture
Chamber, Slide Culture (KIY): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Chamber, Slide Culture (product code KIY, Class 1, 21 CFR 864.2240). 2 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 September 27, 1978, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KIY
- Device class
- 1
- Regulation
- 864.2240
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| United States | 3 |
| South Korea | 1 |
Makers of Chamber, Slide Culture
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 |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | September 27, 1978 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | September 27, 1978 | 0 | 0 | 0 | api.fda.gov |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cnooc Yonglian Pharmaceutical Innovation (hainan) Co., Ltd. | Qionghai Hainan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cytogen, Inc. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Erie Scientific LLC | Portsmouth, NH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 27, 1978. 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.