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510(k) K862858

CBC-CAL (TM) PLUS/MULTIPLE by R&D Systems, Inc. — Product Code KRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1986
Date Received
July 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Cell Indices
Device Class
Class II
Regulation Number
864.8150
Review Panel
HE
Submission Type

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  • K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 (August 20, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)

Other clearances for product code KRX

  • K160585 — XN CAL (December 22, 2016)
  • K141955 — XN CAL PF (December 5, 2014)
  • K141962 — XN CAL (December 5, 2014)
  • K120747 — XN CAL PF (October 22, 2012)
  • K120745 — XN CAL (October 19, 2012)
  • K111204 — CELL-DYN 22 PLUS CALIBRATOR (December 22, 2011)
  • K083200 — X-CAL (February 3, 2009)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K003991 — CD-CAL PLUS CALIBRATOR (January 16, 2001)
  • K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (December 20, 1999)