FDA 510(k)

XN CHECK BF

K-Number: K160588 · 2016-12-22

ApplicantStreck

Decision Date2016-12-22

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

XN CHECK BF 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 K160588. 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 CHECK BF?

XN CHECK BF is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Streck. The 510(k) number is K160588.

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

XN CHECK BF received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160588.

Who is the listed applicant for XN CHECK BF?

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 CHECK BF?

The FDA product code for XN CHECK BF 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 K160586XN-L CHECKStreck 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.