510(k) K052549 ยท DOF Lead, Atomic Absorption
LEADCARE II BLOOD LEAD TESTING SYSTEM
| Applicant | Esa Biosciences, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Oct 6, 2005 |
| Received | Sep 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Magellan Diagnostics, Inc. LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. Open, Classified |
DOF | None listed |
| Apr 17, 2026 | Magellan Diagnostics, Inc. (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ;
Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Tes Open, Classified |
DOF | None listed |
| Apr 17, 2026 | Magellan Diagnostics, Inc. LeadCare Ultra Blood Lead Test Kit;
Catalog Number: 70-8098;
The LeadCare Ultra kit is provided with the following materials:
" Sensors (8 containers of 24 each; 192 tests)
" Treatment Reagent Tubes Open, Classified |
DOF | None listed |
| Nov 21, 2025 | Magellan Diagnostics, Inc. The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.
The LeadCare II Test Kit is provided with the following materials:
" Sensors (2 Co Open, Classified |
DOF | None listed |
| Nov 3, 2023 | Magellan Diagnostics, Inc. LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood. Open, Classified |
DOF | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests
Model Number: 70-6762 Open, Classified |
DOF | None listed |
| Jul 1, 2021 | Magellan Diagnostics, Inc. LeadCare II Blood Lead Test Kit
Catalog Number 70-6762 Terminated |
DOF | None listed |
| 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 |
| Jan 9, 2018 | Magellan Diagnostics, Inc. LeadCare II Blood Lead Analyzer
Part Numbers: 70-6760, 70-6529-R, 70-6760-P,
70-6760-R.
Intended for in vitro (external) use only. Terminated |
DOF | None listed |
| Aug 15, 2017 | Magellan Diagnostics, Inc. LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls
Product Usage:
IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls Terminated |
DOF | None listed |
| Jun 5, 2017 | Magellan Diagnostics, Inc. Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits.
Product Usage:
The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measureme Terminated |
DOF | None listed |
| Oct 18, 2007 | Esa Biosciences, Inc. ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A
Catalog Number: 70-6762 Terminated |
DOF | None listed |
| Oct 18, 2007 | Esa Biosciences, Inc. ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A
Catalog Number: 70-7142 Terminated |
DOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.