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510(k) K024173

CDS 3-PD HEMATOLOGY CONTROLS by Clinical Diagnostic Solutions, Inc. — Product Code JPK

K024173 is an FDA 510(k) premarket notification submitted by Clinical Diagnostic Solutions, Inc. for the device "CDS 3-PD HEMATOLOGY CONTROLS". The FDA issued a decision of Substantially Equivalent on January 14, 2003. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Clinical Diagnostic Solutions, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2003
Date Received
December 18, 2002
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 Clinical Diagnostic Solutions, Inc.

  • K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL) (June 10, 2004)
  • K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (December 20, 1999)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K141964 — XN CHECK (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