510(k) K142705
- Device
- LeadCare Plus Blood Lead Testing System
- Applicant
- Magellan Diagnostics
- 510(k) number
- K142705
- Product code
- DOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-07
- Date received
- 2014-09-22
- Regulation
- 862.3550
- Classification name
- Lead, Atomic Absorption
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Reba Daoust
- Address
- 101 Billerica Ave., Bldg. 4 N. Billerica MA US 01862 01862
FDA Registration Numbers#
- 3043226252
- 3012494290
- 1218996
Source Documents#
Other 510(k) Records For Product Code DOF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | Magellan Diagnostics | 2013-08-20 |
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM | Esa Biosciences, Inc. | 2005-10-06 |
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM | Esa, Inc. | 1997-09-09 |
| K936060 | ATOMSPEC GF BLOOD LEAD WORKSTATION | Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1994-09-06 |
| K843839 | STAT/PB REAGENT | Tri-Tech, Inc. | 1985-01-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary