Panels › Clinical Toxicology › Product code DOF · Class 2
Lead, Atomic Absorption
Regulation 862.3550
0510(k)s in 12 months (6 all time)
5recalls in 12 months (21 all time)
21recalls that name a 510(k)
Top companies in DOF
| Company | 510(k)s | Recalls |
|---|---|---|
| Magellan Diagnostics | 2 | 17 |
| Esa Biosciences, Inc. | 1 | 3 |
| Esa, Inc. | 1 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1 | 0 |
| Tri-Tech, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2015 | K142705 | LeadCare Plus Blood Lead Testing System Magellan Diagnostics | DOF |
| Aug 20, 2013 | K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM Magellan Diagnostics | DOF |
| Oct 6, 2005 | K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM Esa Biosciences, Inc. | DOF |
| Sep 9, 1997 | K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM Esa, Inc. | DOF |
| Sep 6, 1994 | K936060 | ATOMSPEC GF BLOOD LEAD WORKSTATION Thermo Jarrell Ash Corp.Div.Thermo Inst. | DOF |
| Jan 3, 1985 | K843839 | STAT/PB REAGENT Tri-Tech, Inc. | DOF |
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