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510(k) K160586

XN-L CHECK by Streck — Product Code JPK

K160586 is an FDA 510(k) premarket notification submitted by Streck for the device "XN-L CHECK". The FDA issued a decision of Substantially Equivalent on December 22, 2016. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. 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
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
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)
  • K160588 — XN CHECK BF (December 22, 2016)

Other clearances for product code JPK

  • K160588 — XN CHECK BF (December 22, 2016)
  • K160590 — XN CHECK (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)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)
  • K100790 — COULTER LIN-X LINEARITY CONTROL, MODEL A81196 (December 21, 2010)

FDA data resources