510(k) Report

FDA applicant

Magellan Diagnostics

N. Billerica, MA2 decisions2013–20156 recalls

FDA records 2 decisions for Magellan Diagnostics (N. Billerica, MA) from 2013 to 2015: 2 510(k) clearances. All are in product code DOF (Lead, Atomic Absorption). Its devices cite 2 predicates, 1 of them its own earlier devices. 6 recalls are linked to its devices, 4 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Magellan Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2026

2014: 2, 2 Class I2018: 12021: 2, 2 Class I2026 (partial year): 1
2013high 2 (2014) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Magellan Diagnostics by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DOFLead, Atomic Absorption2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 20131cites it

What has FDA decided for it lately?

  • K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 20152 Class I recalls
  • K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 20132 Class I recalls

All 2 as Magellan Diagnostics →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K142705LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is…Mar 13, 2026Class II
  • K142705LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004May 7, 2021Class I
  • K123563LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098May 7, 2021Class I
  • K142705LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative…Jan 9, 2018Class II
  • K123563Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010Nov 29, 2014Class I
  • K142705Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010Nov 29, 2014Class I