XN CHECK
K-Number: K160590 · 2016-12-22
ApplicantStreck
Decision Date2016-12-22
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
XN CHECK is a medical device manufactured by Streck. It received FDA 510(k) clearance on 2016-12-22 under approval number K160590. 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?
XN 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 K160590.
When was XN CHECK approved by the FDA?
XN CHECK received FDA 510(k) clearance on 2016-12-22, under approval number K160590.
What company makes XN CHECK?
XN CHECK is manufactured by Streck.
What is the FDA product code for XN CHECK?
The FDA product code for XN 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.