DIAPLUS Universal
K-Number: K213401 · 2022-01-31
ApplicantDiaDent Group International
Decision Date2022-01-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DIAPLUS Universal is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2022-01-31 under approval number K213401. 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 Universal?
DIAPLUS Universal is a medical device that received FDA 510(k) clearance on 2022-01-31. It is manufactured by DiaDent Group International. The 510(k) number is K213401.
When was DIAPLUS Universal approved by the FDA?
DIAPLUS Universal received FDA 510(k) clearance on 2022-01-31, under approval number K213401.
What company makes DIAPLUS Universal?
DIAPLUS Universal is manufactured by DiaDent Group International.
What is the FDA product code for DIAPLUS Universal?
The FDA product code for DIAPLUS Universal 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.