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Runbio Biotech Co.,Ltd

FDA Regulatory Profile

Runbio Biotech Co.,Ltd has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 24, 2014 · NAI
Latest 510(k)
Feb 22, 2019

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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
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 24, 2014Shantou, ChinaDevicesNo Action Indicated (NAI)3005216656

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
K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip…Feb 22, 2019
K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteMar 28, 2018
K053236DAVID PREGNANCY TEST (MIDSTREAM)Jul 18, 2006

FDA data resources