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Broadmaster Biotech, Corp.

FDA Regulatory Profile

Broadmaster Biotech, Corp. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 1 compliance action on record.

Latest inspection
Apr 13, 2023 · OAI
Latest 510(k)
Sep 5, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 13, 2023Taoyuan City, TaiwanDevicesOfficial Action Indicated (OAI)3009276320

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
K191004Advocate Non-Contact Infrared ThermometerSep 5, 2019
K180355Advocate Non-Contact Infrared ThermometerJan 10, 2019
K130621BROADMASTER HEALTHCARE SYSTEMJul 30, 2013
K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEMOct 7, 2011

FDA data resources