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FDA 510(k)

Detectabuse Flüssigkeitskontrollurin, Detectabuse Stat-Skreen Flüssigkeitskontrollurin, Detectabuse Flüssigkeitskontrollurin, AU/NZ, Detectabuse Flüssigkeitskontrollurin, Immunoassay-Serie, Detectabuse Flüssigkeitskontrollurin, GC/MS und Bestätigungsserie

K-Nummer: K153474 · 2016-02-23

AntragstellerBiochemical Diagnostics, Inc.
Entscheidungsdatum2016-02-23
ProduktcodeDIF
BeratungsausschussTX
EntscheidungSubstantially Equivalent

Produktübersicht

Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K153474. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series?

Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Biochemical Diagnostics, Inc.. The 510(k) number is K153474.

When did Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series receive FDA 510(k) clearance?

Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series received FDA 510(k) clearance on 2016-02-23, under 510(k) number K153474.

Who is the listed applicant for Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series?

The FDA 510(k) record lists Biochemical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series?

The FDA product code for Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series is DIF.

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NCT07608549FLASH Pilot Phase 1 SicherheitstudieNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Künstlich-intelligenz-assistiertes Uro-Cam Katheter-Assessment-System zur Diagnose von BlasenkrebsNOT_YET_RECRUITING

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