DiaPlus
K-Number: K192392 · 2020-05-26
ApplicantDiaDent Group International
Decision Date2020-05-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DiaPlus is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-05-26 under approval number K192392. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DiaPlus?
DiaPlus is a medical device that received FDA 510(k) clearance on 2020-05-26. It is manufactured by DiaDent Group International. The 510(k) number is K192392.
When was DiaPlus approved by the FDA?
DiaPlus received FDA 510(k) clearance on 2020-05-26, under approval number K192392.
What company makes DiaPlus?
DiaPlus is manufactured by DiaDent Group International.
What is the FDA product code for DiaPlus?
The FDA product code for DiaPlus is KLE.
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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.