FDA 510(k)

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card

Numéro K : K163704 · 2017-08-02

Date de décision2017-08-02

Code produitJXM

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2017-08-02 under 510(k) number K163704. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2017-08-02. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K163704.

When did Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card receive FDA 510(k) clearance?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2017-08-02, under 510(k) number K163704.

Who is the listed applicant for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

The FDA product code for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is JXM.

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Dispositifs connexes (Code : JXM)

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Source officielle

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