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OSANG Healthcare CO., LTD.

FDA Regulatory Profile

OSANG Healthcare CO., LTD. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 1 compliance action on record.

Latest inspection
Feb 20, 2014 · OAI
Latest 510(k)
Jul 13, 2021

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 20, 2014Anyang, Korea (The Republic Of)DevicesOfficial Action Indicated (OAI)3004146366
May 13, 2011Anyang, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3004146366

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
K203562Finetest Lite Blood Glucose Monitoring SystemJul 13, 2021
K201396Finetest Lite Smart Blood Glucose Monitoring SystemOct 16, 2020
K182286Oh'Care Lite Smart Blood Glucose Monitoring SystemSep 19, 2018

FDA data resources