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510(k) K123563

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM by Magellan Diagnostics — Product Code DOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2013
Date Received
November 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lead, Atomic Absorption
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
Submission Type

Other clearances by Magellan Diagnostics

  • K142705 — LeadCare Plus Blood Lead Testing System (July 7, 2015)

Other clearances for product code DOF

  • K142705 — LeadCare Plus Blood Lead Testing System (July 7, 2015)
  • K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEM (October 6, 2005)
  • K971640 — LEADCARE BLOOD LEAD TESTING SYSTEM (September 9, 1997)
  • K936060 — ATOMSPEC GF BLOOD LEAD WORKSTATION (September 6, 1994)
  • K843839 — STAT/PB REAGENT (January 3, 1985)