FDA product code DOF: Lead, Atomic Absorption
DOF is the FDA product code for lead, atomic absorption. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under DOF, from 5 different applicants. The average 510(k) review took 178 days (median 195). FDA has posted 20 recalls for DOF devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lead, Atomic Absorption |
| Device class | Class II |
| Regulation | 21 CFR 862.3550 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every DOF clearance
Top DOF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Magellan Diagnostics | 2 | 2015-07-07 |
| Esa Biosciences, Inc. | 1 | 2005-10-06 |
| Esa, Inc. | 1 | 1997-09-09 |
| Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1 | 1994-09-06 |
| Tri-Tech, Inc. | 1 | 1985-01-03 |
Most recent DOF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142705 | Magellan Diagnostics | LeadCare Plus Blood Lead Testing System | 2015-07-07 | 288 |
| K123563 | Magellan Diagnostics | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | 2013-08-20 | 274 |
| K052549 | Esa Biosciences, Inc. | LEADCARE II BLOOD LEAD TESTING SYSTEM | 2005-10-06 | 20 |
| K971640 | Esa, Inc. | LEADCARE BLOOD LEAD TESTING SYSTEM | 1997-09-09 | 130 |
| K936060 | Thermo Jarrell Ash Corp.Div.Thermo Inst. | ATOMSPEC GF BLOOD LEAD WORKSTATION | 1994-09-06 | 260 |
Recalls for DOF devices
20 product recalls in 12 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-03-13.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 3 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code DOF?
DOF is the FDA product code for lead, atomic absorption. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel.
What device class is DOF?
Class II, regulation 21 CFR 862.3550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOF?
Across 6 cleared submissions the average was 178 days from receipt to decision (median 195).
Which companies have the most DOF clearances?
Magellan Diagnostics (2); Esa Biosciences, Inc. (1); Esa, Inc. (1); Thermo Jarrell Ash Corp.Div.Thermo Inst. (1); Tri-Tech, Inc. (1).
Have DOF devices been recalled?
Yes: 20 product recalls across 12 recall events; the most recent began 2026-03-13.
Next steps
- Run an FDA pathway report with predicate devices for product code DOF
- Run a recall and safety report across every DOF manufacturer
- Watch product code DOF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times