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510(k) K971640

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1997
Date Received
May 2, 1997
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 Esa, Inc.

  • K032199 — ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (January 30, 2004)
  • K963938 — MODEL 5500 CEAS (December 26, 1996)
  • K934977 — MODEL 5500 CEAS (January 11, 1994)
  • K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (June 9, 1993)
  • K903231 — COULOCHEM II (September 27, 1990)
  • K864729 — NEUROCHEMICAL ANALYZER (April 13, 1987)

Other clearances for product code DOF

  • K142705 — LeadCare Plus Blood Lead Testing System (July 7, 2015)
  • K123563 — LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (August 20, 2013)
  • K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEM (October 6, 2005)
  • K936060 — ATOMSPEC GF BLOOD LEAD WORKSTATION (September 6, 1994)
  • K843839 — STAT/PB REAGENT (January 3, 1985)