FDA device listing
Aerospray® 12-Slide Carousel,Aerospray® 30-Slide Carousel,Aerospray® Cytology 12-Slide Carousel,Aerospray® Cytology…
FDA device listing 1275132654 · ELITechGroup Inc.
Key facts
| Proprietary names | Aerospray® 12-Slide Carousel,Aerospray® 30-Slide Carousel,Aerospray® Cytology 12-Slide Carousel,Aerospray® Cytology 30-Slide Carousel,Aerospray® Cytology Slide Stainer/Cytocentrifuge, Model 7522,Aerospray® Cytology Stain F Empty Bottle w/Level Detect,Aerospray® Gram Slide Stainer/Cytocentrifuge, Model 7322,Aerospray® Hematology Pro Slide Stainer/Cytocentrifuge, Model 7152,Aerospray® Hematology… |
|---|---|
| Owner/operator | ELITechGroup Inc. |
| Owner/operator number | 1717966 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | ELITechGroup Inc |
| Establishment registrations | 1717966 |
| FEI numbers | 1717966 |
| Establishment operations | Manufacturer |
| 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