ARCHITECT SHBG
K-Number: K152185 · 2016-02-11
ApplicantBiokit, S.A.
Decision Date2016-02-11
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ARCHITECT SHBG is a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2016-02-11 under approval number K152185. 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 ARCHITECT SHBG?
ARCHITECT SHBG is a medical device that received FDA 510(k) clearance on 2016-02-11. It is manufactured by Biokit, S.A.. The 510(k) number is K152185.
When was ARCHITECT SHBG approved by the FDA?
ARCHITECT SHBG received FDA 510(k) clearance on 2016-02-11, under approval number K152185.
What company makes ARCHITECT SHBG?
ARCHITECT SHBG is manufactured by Biokit, S.A..
What is the FDA product code for ARCHITECT SHBG?
The FDA product code for ARCHITECT SHBG 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.