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 a medical device manufactured by Streck. It received FDA 510(k) clearance on 2016-12-22 under approval 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. It is manufactured by Streck. The 510(k) number is K160586.
When was XN-L CHECK approved by the FDA?
XN-L CHECK received FDA 510(k) clearance on 2016-12-22, under approval number K160586.
What company makes XN-L CHECK?
XN-L CHECK is manufactured by Streck.
What is the FDA product code for XN-L CHECK?
The FDA product code for XN-L CHECK is JPK.
Other Devices by Streck
Related Devices (Code: JPK)
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.