510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DOFClass II

Lead, Atomic Absorption

21 CFR 862.3550 / Clinical Toxicology
FDA source (opens on fda.gov)

DOF is the FDA product code for Lead, Atomic Absorption, a class II device type, regulated under 21 CFR 862.3550. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
DOF
Device name
Lead, Atomic Absorption
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
20

Clearances, product code DOF

By decision year
6 clearances under product code DOF with a decision year between 1985 and 2015, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DOF by decision year
YearClearances
19851
19941
19971
20051
20131
20151

Applicants with the most clearances

Product code DOF
Applicants holding the most 510(k) clearances under product code DOF
ApplicantClearances
Magellan Diagnostics, Inc.3
Esa, Inc.1
Thermo Jarrell Ash Corp.Div.Thermo Inst.1
Tri-Tech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code