Free Testosterone AccuBind ELISA Test System
K-Number: K181017 · 2018-07-20
ApplicantMonobind, Inc.
Decision Date2018-07-20
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Free Testosterone AccuBind ELISA Test System is a medical device manufactured by Monobind, Inc.. It received FDA 510(k) clearance on 2018-07-20 under approval number K181017. 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 Free Testosterone AccuBind ELISA Test System?
Free Testosterone AccuBind ELISA Test System is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Monobind, Inc.. The 510(k) number is K181017.
When was Free Testosterone AccuBind ELISA Test System approved by the FDA?
Free Testosterone AccuBind ELISA Test System received FDA 510(k) clearance on 2018-07-20, under approval number K181017.
What company makes Free Testosterone AccuBind ELISA Test System?
Free Testosterone AccuBind ELISA Test System is manufactured by Monobind, Inc..
What is the FDA product code for Free Testosterone AccuBind ELISA Test System?
The FDA product code for Free Testosterone AccuBind ELISA 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.