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510(k) K844897

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

K844897 is an FDA 510(k) premarket notification submitted by Medical Specialties Laboratories for the device "HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8". The FDA issued a decision of Substantially Equivalent on March 22, 1985. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Medical Specialties Laboratories has at least 4 other 510(k) clearances on record.

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

  • 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)

FDA data resources