FJD
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Detector, Leak, Blood
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2004: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| E-Z CHEK BLOOD LEAK TEST STRIPS (K123805) | Reprocessing Products Corp | 2013-03-20 |
| STERICHEK BLOOD LEAK REAGENT STRIPS (K042322) | Hach Company | 2004-12-07 |
| SERIM BLOOD LEAK TEST STRIP-2 (K012115) | Serim Research Corp. | 2001-11-30 |
| SERIM BLOOD LEAK TEST STRIP (K990206) | Serim Research Corp. | 1999-04-21 |
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Every clearance here is in the API, with alerts when new ones post.