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510(k) K844897

HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 by Medical Specialties Laboratories — Product Code JPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1985
Date Received
December 17, 1984
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 Medical Specialties Laboratories

  • K852643 — UNI-PLATE (August 8, 1985)
  • K840114 — COAGULATION FACTOR DEFICIENT PLASMA (February 4, 1984)
  • K823587 — UNI-CELL (January 5, 1983)
  • K810268 — NORMLCERA (March 6, 1981)

Other clearances for product code JPK

  • K160590 — XN CHECK (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (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)