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510(k) K160585

XN CAL by Streck — Product Code KRX

K160585 is an FDA 510(k) premarket notification submitted by Streck for the device "XN CAL". The FDA issued a decision of Substantially Equivalent on December 22, 2016. The device falls under product code KRX (Calibrator For Cell Indices), a Class II device regulated under 21 CFR 864.8150. Streck has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2016
Date Received
March 1, 2016
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

Other clearances by Streck

  • K260041 — MDx-Chex for BCP (March 27, 2026)
  • K254166 — MDx-Chex for BCN (March 23, 2026)
  • K254167 — MDx-Chex for BCY (March 17, 2026)
  • K231776 — Cell-Free DNA BCT (July 26, 2024)
  • K231221 — MDx-Chex for BC-GP (July 27, 2023)
  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • DEN200001 — Cell-Free DNA BCT (August 7, 2020)
  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K160586 — XN-L CHECK (December 22, 2016)

Other clearances for product code KRX

  • K141962 — XN CAL (December 5, 2014)
  • K141955 — XN CAL PF (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)
  • K955925 — CBC-CAL PLUS HEMATOLOGY CALIBRATOR (February 29, 1996)

FDA data resources