Xn-L Check

FDA 510(k) K160586 · Streck

Substantially Equivalent

510(k) numberK160586

Submission

Device name
Xn-L Check
Applicant
Streck
La Vista, NE, US
Received
March 1, 2016
Decision date
December 22, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JPK – Mixture, Hematology Quality Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

Other 510(k)s with product code JPK

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K160590XN CheckJPK · Traditional Streck12/22/2016SE
K160588XN Check BFJPK · Traditional Streck12/22/2016SE
K160606BC-5D Hematology ControlJPK · Traditional R&D Systems, Inc.09/01/2016SE
K141964XN CheckJPK · Traditional Streck12/05/2014SE
K141957XN Check BFJPK · Traditional Streck12/05/2014SE
K130962R&D 5D Retic Hematology ControlJPK · Special R&D Systems, Inc.07/24/2013SE
K120744XN Check BFJPK · Traditional Streck10/19/2012SE
K120742XN CheckJPK · Traditional Streck10/19/2012SE
K101578R&D Systems Body Fluid-I Hematology ControlJPK · Traditional R&D Systems, Inc.04/28/2011SE
K100790Coulter Lin-X Linearity Control, Model A81196JPK · Traditional Beckman Coulter, Inc.12/21/2010SE

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K160590XN CheckJPK · Traditional 12/22/2016SE
K160588XN Check BFJPK · Traditional 12/22/2016SE

Questions and answers

When was Xn-L Check cleared by the FDA?

Xn-L Check (K160586) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 296 days after the submission was received.

What is the product code of K160586?

The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.