LeadCare Plus Blood Lead Testing System— 510(k) K142705
Substantially EquivalentMagellan Diagnostics
FDA 510(k) clearance K142705 for LeadCare Plus Blood Lead Testing System, Substantially Equivalent on 2015-07-07. Applicant: Magellan Diagnostics. Device class: 2.
Clearance details
- Applicant
- Magellan Diagnostics
- Product code
- Code DOF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3550
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- N. Billerica, MA, US
Recent devices under product code DOF
view allRecalls naming K142705
K-number listed on FDA's recall record- Z-1894-2026 — 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 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
- Z-1953-2021 — LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
- Z-1296-2018 — LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
- Z-1926-2017 — Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142705.
Data sourced from openFDA. This site is unofficial and independent of the FDA.