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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 a medical device manufactured by Streck. It received FDA 510(k) clearance on 2016-12-22 under approval 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. It is manufactured by Streck. The 510(k) number is K160588.

When was XN CHECK BF approved by the FDA?

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

What company makes XN CHECK BF?

XN CHECK BF is manufactured by Streck.

What is the FDA product code for XN CHECK BF?

The FDA product code for XN CHECK BF is JPK.

Other Devices by Streck

K160590XN CHECK K160585XN CAL K160586XN-L CHECK K170091UA-Cellular Complete K231223MDx-Chex for BC-GN K231221MDx-Chex for BC-GP

View all 8 devices →

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.

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