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510(k) K052549

LEADCARE II BLOOD LEAD TESTING SYSTEM by Esa Biosciences, Inc. — Product Code DOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2005
Date Received
September 16, 2005
Clearance Type
Special
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 Esa Biosciences, Inc.

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  • K936060 — ATOMSPEC GF BLOOD LEAD WORKSTATION (September 6, 1994)
  • K843839 — STAT/PB REAGENT (January 3, 1985)