KLH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, C. Acnes
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3140
- Medical specialty
- Microbiology
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| OXYMETER & TRANSOXODE (K801858) | Thoracel | 1980-08-13 | + Add |
Track KLH automatically
Every clearance here is in the API, with alerts when new ones post.