MJE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Culture Media, Antifungal, Susceptibility Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
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 |
|---|---|---|---|
| RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (K072827) | Remel, Inc. | 2007-11-26 | + Add |
Track MJE automatically
Every clearance here is in the API, with alerts when new ones post.