IFP
15 FDA 510(k) clearances · Product code
28 daysmedian time to decision
57 days90th percentile
15clearances measured
FDA profile
- Official device name
- Formalin, Neutral Buffered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 2 · 1999: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Track IFP automatically
Every clearance here is in the API, with alerts when new ones post.