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510(k) K142705

LeadCare Plus Blood Lead Testing System by Magellan Diagnostics — Product Code DOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2015
Date Received
September 22, 2014
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

  • K123563 — LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (August 20, 2013)

Other clearances for product code DOF

  • K123563 — LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (August 20, 2013)
  • 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)