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FDA 510(k) Applications Submitted by BRYAN FANG
FDA 510(k) Number
Submission Date
Device Name
Applicant
K240949
04/08/2024
Healgen« Accurate Fentanyl Rapid Test Cassette (Urine); Healgen« Accurate Rapid Fentanyl Test Cassette (Urine); Healgen« Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen« Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen« Accurate Fentanyl Rapi
Healgen Scientific LLC
K221871
06/28/2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Healstone Biotech Inc
K191841
07/09/2019
Accurate Multi Panel Drug Urine Test Cup
Healstone Biotech Inc
K123703
12/03/2012
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
HEALGEN SCIENTIFIC, LLC
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