FREND Testosterone Test System
K-Number: K153577 · 2016-10-14
ApplicantNanoentek USA, Inc.
Decision Date2016-10-14
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
FREND Testosterone Test System is a medical device manufactured by Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2016-10-14 under approval number K153577. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FREND Testosterone Test System?
FREND Testosterone Test System is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Nanoentek USA, Inc.. The 510(k) number is K153577.
When was FREND Testosterone Test System approved by the FDA?
FREND Testosterone Test System received FDA 510(k) clearance on 2016-10-14, under approval number K153577.
What company makes FREND Testosterone Test System?
FREND Testosterone Test System is manufactured by Nanoentek USA, Inc..
What is the FDA product code for FREND Testosterone Test System?
The FDA product code for FREND Testosterone Test System is CDZ.
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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.