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Scientific Intake

FDA Regulatory Profile

Scientific Intake has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 11, 2019 · VAI
Latest 510(k)
May 18, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 11, 2019Gainesville, GADevicesVoluntary Action Indicated (VAI)3004501997

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K171165SmartByte DeviceMay 18, 2017
DEN150033Sensor Monitored Alimentary Restriction Therapy (SMART) DeviceSep 26, 2016

FDA data resources