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510(k) K120747

XN CAL PF by Streck — Product Code KRX

K120747 is an FDA 510(k) premarket notification submitted by Streck for the device "XN CAL PF". The FDA issued a decision of Substantially Equivalent on October 22, 2012. 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
October 22, 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

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)
  • K160585 — XN CAL (December 22, 2016)

Other clearances for product code KRX

  • K160585 — XN CAL (December 22, 2016)
  • K141962 — XN CAL (December 5, 2014)
  • K141955 — XN CAL PF (December 5, 2014)
  • 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