510(k) K142705 ยท DOF Lead, Atomic Absorption
LeadCare Plus Blood Lead Testing System
| Applicant | Magellan Diagnostics, N. Billerica MA, US |
| Decision | Substantially Equivalent, Jul 7, 2015 |
| Received | Sep 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2026 | Magellan Diagnostics, Inc. LeadCare Plus Blood Lead Test Kit;
Catalog Number: 82-0004;
The LeadCare Plus kit is provided with the following materials:
" Sensors (4 containers of 24 each; 96 tests)
" Treatment Reagent Tubes (4 Open, Classified |
DOF | None listed |
| Jul 1, 2021 | Magellan Diagnostics, Inc. LeadCare Plus Blood Lead Test Kit
Catalog Number 82-0004 Terminated |
DOF | None listed |
| Jan 9, 2018 | Magellan Diagnostics, Inc. LeadCare Plus Blood Lead Analyzer
Part Number: 82-0001
Intended for the quantitative measurement of lead in a whole blood sample. Terminated |
DOF | None listed |
| May 18, 2017 | Magellan Diagnostics, Inc. Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits
Part Number: 80-0010 Terminated |
DOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.