PREVENT Kit
K-Number: K232379 · 2024-02-05
ApplicantClear Choice Therapeutics
Decision Date2024-02-05
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PREVENT Kit is a medical device manufactured by Clear Choice Therapeutics. It received FDA 510(k) clearance on 2024-02-05 under approval number K232379. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PREVENT Kit?
PREVENT Kit is a medical device that received FDA 510(k) clearance on 2024-02-05. It is manufactured by Clear Choice Therapeutics. The 510(k) number is K232379.
When was PREVENT Kit approved by the FDA?
PREVENT Kit received FDA 510(k) clearance on 2024-02-05, under approval number K232379.
What company makes PREVENT Kit?
PREVENT Kit is manufactured by Clear Choice Therapeutics.
What is the FDA product code for PREVENT Kit?
The FDA product code for PREVENT Kit is OMP.
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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.