510(k) K123563 ยท DOF Lead, Atomic Absorption
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
| Applicant | Magellan Diagnostics, N. Billerica MA, US |
| Decision | Substantially Equivalent, Aug 20, 2013 |
| Received | Nov 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2021 | Magellan Diagnostics, Inc. LeadCare Ultra Blood Lead Test Kit
Catalog Number 70-8098 Terminated |
DOF | None listed |
| May 18, 2017 | Magellan Diagnostics, Inc. Magellan Diagnostics LeadCare Ultra Blood Analyzer
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.