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510(k) K120745

XN CAL by Streck — Product Code KRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2012
Date Received
March 12, 2012
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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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)
  • 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)
  • K955925 — CBC-CAL PLUS HEMATOLOGY CALIBRATOR (February 29, 1996)