510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123563Substantially Equivalent

Leadcare (R) Ultra (Tm) Blood Lead Testing System

Magellan Diagnostics, Inc., N. Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123563 is the FDA 510(k) clearance record for LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM, a class II device, cleared for Magellan Diagnostics on under FDA product code DOF (Lead, Atomic Absorption). FDA records list 4 510(k) clearances for Magellan Diagnostics, from to . As of , FDA records show 2 recalls naming K123563.

Clearance record

Decision date
Received
(274 days to decision)
Product code
DOF Lead, Atomic Absorption
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Magellan Diagnostics 101 Billerica Ave., Bldg. 4, N. Billerica MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DOF

Trailing 12 months

FDA records hold no clearances under product code DOF in the trailing twelve months.

FDA records show no clearances under product code DOF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DOF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260