510(k) K971640 ยท DOF Lead, Atomic Absorption
LEADCARE BLOOD LEAD TESTING SYSTEM
| Applicant | Esa, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Sep 9, 1997 |
| Received | May 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2018 | Magellan Diagnostics, Inc. Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood.
Catalog Number: 70-6762
Primary DI No:
00850355006000
The LeadCare II Blood Lead Test Kit is Terminated |
DOF | None listed |
| Jun 5, 2017 | Magellan Diagnostics, Inc. Magellan Diagnostics LeadCare and LeadCare II test Kits.
Product Usage:
The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of l Terminated |
DOF | None listed |
| Jun 21, 2005 | Esa Biosciences, Inc. LeadCare Blood Lead Testing System Kits
Catalog Number: 70-2233 Terminated |
DOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.