Lead, Atomic Absorption
The Lead Atomic Absorption test is a clinical laboratory device that uses atomic absorption spectroscopy to detect and measure lead concentrations in blood or other biological specimens, providing a direct assessment of lead exposure and poisoning. It is a Class 2 device requiring a 510(k) premarket notification before marketing. The product code is DOF, regulated under 21 CFR 862.3550, within the Clinical Toxicology specialty. No special regulatory flags apply.
Basic Information
- Product Code
- DOF
- Device Class
- FDA class 2
- Regulation Number
- 862.3550
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142705 | LeadCare Plus Blood Lead Testing System | Jul 07, 2015 | Substantially Equivalent | Magellan Diagnostics |
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | Aug 20, 2013 | Substantially Equivalent | Magellan Diagnostics |
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM | Oct 06, 2005 | Substantially Equivalent | Esa Biosciences, Inc. |
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM | Sep 09, 1997 | Substantially Equivalent | Esa, Inc. |
| K936060 | ATOMSPEC GF BLOOD LEAD WORKSTATION | Sep 06, 1994 | Substantially Equivalent | Thermo Jarrell Ash Corp.Div.Thermo Inst. |
| K843839 | STAT/PB REAGENT | Jan 03, 1985 | Substantially Equivalent | Tri-Tech, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.