XN Cal

FDA 510(k) K160585 · Streck

Substantially Equivalent

510(k) numberK160585

Submission

Device name
XN Cal
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
KRX – Calibrator For Cell Indices
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8150
Specialty
Hematology

Other 510(k)s with product code KRX

510(k)DeviceApplicantDecision
K141962XN CalKRX · Traditional Streck12/05/2014SE
K141955XN Cal PFKRX · Traditional Streck12/05/2014SE
K120747XN Cal PFKRX · Traditional Streck10/22/2012SE
K120745XN CalKRX · Traditional Streck10/19/2012SE
K111204Cell-Dyn 22 Plus CalibratorKRX · Traditional Streck12/22/2011SE
K083200X-CalKRX · Traditional Streck02/03/2009SE
K020469Cal-Chex CD PlusKRX · Traditional Streck Laboratories, Inc.04/04/2002SE
K003991Cd-Cal Plus CalibratorKRX · Special R&D Systems, Inc.01/16/2001SE
K993375CDS LTX Control Latex Particle Suspension and PrimerKRX · Abbreviated Clinical Diagnostic Solutions, Inc.12/20/1999SE
K955925Cbc-Cal Plus Hematology CalibratorKRX · Traditional R&D Systems, Inc.02/29/1996SE

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K170091UA-Cellular CompleteJJW · Traditional 02/09/2017SE
K160590XN CheckJPK · Traditional 12/22/2016SE
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Questions and answers

When was XN Cal cleared by the FDA?

XN Cal (K160585) 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 K160585?

The FDA product code is KRX – Calibrator For Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8150.