Data / Medical devices / Sprays, Synthetic, Smear
Sprays, Synthetic, Smear (IFI): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Sprays, Synthetic, Smear (product code IFI, Class 1, 21 CFR 864.4010). 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 December 30, 1980, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IFI
- Device class
- 1
- Regulation
- 864.4010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| United States | 2 |
| Canada | 1 |
Makers of Sprays, Synthetic, Smear
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 |
|---|---|---|---|---|---|---|---|---|
| Chaptec America | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecotec Manufacturing | Okeechobee, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiaoyue Pharmaceutical (huizhou) Co.ltd | Huizhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Cooskin Stationery Co., Ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 30, 1980. 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.