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510(k) K830864

WHITE BLOOD CELL CONTROL by Control Diagnostics — Product Code JPK

K830864 is an FDA 510(k) premarket notification submitted by Control Diagnostics for the device "WHITE BLOOD CELL CONTROL". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Control Diagnostics has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1983
Date Received
March 18, 1983
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

Other clearances by Control Diagnostics

  • K833929 — WHITE BLOOD CELLS HUMAN TAND B (February 3, 1984)

Other clearances for product code JPK

  • K160588 — XN CHECK BF (December 22, 2016)
  • K160586 — XN-L CHECK (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)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K120742 — XN CHECK (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources