Product code DOF— Clinical Toxicology

FDA has cleared 6 devices under product code DOF between 1985 and 2015, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20151 clearance
• 20131 clearance
• 20051 clearance
• 19971 clearance
• 19941 clearance
• 19851 clearance

• Magellan Diagnostics2 clearances
• Tri-Tech, Inc.1 clearance
• Thermo Jarrell Ash Corp.Div.Thermo Inst.1 clearance
• Esa, Inc.1 clearance
• Esa Biosciences, Inc.1 clearance

• K142705 — LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics·2015-07-07
• K123563 — LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEMMagellan Diagnostics·2013-08-20
• K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.·2005-10-06
• K971640 — LEADCARE BLOOD LEAD TESTING SYSTEMEsa, Inc.·1997-09-09
• K936060 — ATOMSPEC GF BLOOD LEAD WORKSTATIONThermo Jarrell Ash Corp.Div.Thermo Inst.·1994-09-06
• K843839 — STAT/PB REAGENTTri-Tech, Inc.·1985-01-03