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510(k) K100607

COULTER 4C-EX 300 CELL CONTROL by Beckman Coulter, Inc. — Product Code JPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
March 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)