FDA 510(k)

XN-L CHECK

K-Number: K160586 · 2016-12-22

ApplicantStreck

Decision Date2016-12-22

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

XN-L CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160586. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XN-L CHECK?

XN-L CHECK is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Streck. The 510(k) number is K160586.

When did XN-L CHECK receive FDA 510(k) clearance?

XN-L CHECK received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160586.

Who is the listed applicant for XN-L CHECK?

The FDA 510(k) record lists Streck as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XN-L CHECK?

The FDA product code for XN-L CHECK is JPK.

Other records listing Streck as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260041MDx-Chex for BCP K254166MDx-Chex for BCN K254167MDx-Chex for BCY K231776Cell-Free DNA BCT K231223MDx-Chex for BC-GN K231221MDx-Chex for BC-GP

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Related Devices (Code: JPK)

K160590XN CHECKStreck K160588XN CHECK BFStreck K160606BC-5D Hematology ControlR&D Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.