DOF
6 FDA 510(k) clearances · Product code
260 daysmedian time to decision
288 days90th percentile
6clearances measured
FDA profile
- Official device name
- Lead, Atomic Absorption
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3550
- Medical specialty
- Clinical Toxicology
- Adverse events (MAUDE)
- 2017: 39 · 2018: 40 · 2019: 63 · 2021: 98 · 2025: 55 · 2026: 272
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 |
|---|---|---|
| LeadCare Plus Blood Lead Testing System (K142705) | Magellan Diagnostics | 2015-07-07 |
| LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (K123563) | Magellan Diagnostics | 2013-08-20 |
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |
| LEADCARE BLOOD LEAD TESTING SYSTEM (K971640) | Esa, Inc. | 1997-09-09 |
| ATOMSPEC GF BLOOD LEAD WORKSTATION (K936060) | Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1994-09-06 |
| STAT/PB REAGENT (K843839) | Tri-Tech, Inc. | 1985-01-03 |
Track DOF automatically
Every clearance here is in the API, with alerts when new ones post.