GWD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3220
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MERIFLUOR(TM)-GIARDIA (K873299) | Meridian Diagnostics, Inc. | 1987-09-16 |
| HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER (K844836) | Edward Weck, Inc. | 1985-01-23 |
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Every clearance here is in the API, with alerts when new ones post.