DOF · Class II · 21 CFR 862.3550

FDA Product Code DOF: Lead, Atomic Absorption

Leading manufacturers include Magellan Diagnostics, Esa Biosciences, Inc. and Thermo Jarrell Ash Corp.Div.Thermo Inst..

6
Total
6
Cleared
178d
Avg days
1985
Since

FDA 510(k) Cleared Lead, Atomic Absorption Devices (Product Code DOF)

6 devices
1–6 of 6
Cleared Jul 07, 2015
LeadCare Plus Blood Lead Testing System
K142705
Magellan Diagnostics
Toxicology · 288d
Cleared Aug 20, 2013
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K123563
Magellan Diagnostics
Chemistry · 274d
Cleared Oct 06, 2005
LEADCARE II BLOOD LEAD TESTING SYSTEM
K052549
Esa Biosciences, Inc.
Chemistry · 20d
Cleared Sep 09, 1997
LEADCARE BLOOD LEAD TESTING SYSTEM
K971640
Esa, Inc.
Toxicology · 130d
Cleared Sep 06, 1994
ATOMSPEC GF BLOOD LEAD WORKSTATION
K936060
Thermo Jarrell Ash Corp.Div.Thermo Inst.
Toxicology · 260d

About Product Code DOF - Regulatory Context