DOF — Lead, Atomic Absorption Class II
FDA Device Classification
Classification Details
- Product Code
- DOF
- Device Class
- Class II
- Regulation Number
- 862.3550
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K142705 | magellan diagnostics | LeadCare Plus Blood Lead Testing System | July 7, 2015 |
| K123563 | magellan diagnostics | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | August 20, 2013 |
| K052549 | esa biosciences | LEADCARE II BLOOD LEAD TESTING SYSTEM | October 6, 2005 |
| K971640 | esa | LEADCARE BLOOD LEAD TESTING SYSTEM | September 9, 1997 |
| K936060 | thermo jarrell ash corp.div.thermo inst | ATOMSPEC GF BLOOD LEAD WORKSTATION | September 6, 1994 |
| K843839 | tri-tech | STAT/PB REAGENT | January 3, 1985 |