FDA 510(k)

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)

Numéro K : K160793 · 2016-08-17

Date de décision2016-08-17

Code produitDJR

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) is the device name listed in this FDA 510(k) record. The listed applicant is W.H.P.M., Inc.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K160793. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)?

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is W.H.P.M., Inc.. The 510(k) number is K160793.

When did First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) receive FDA 510(k) clearance?

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) received FDA 510(k) clearance on 2016-08-17, under 510(k) number K160793.

Who is the listed applicant for First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)?

The FDA 510(k) record lists W.H.P.M., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)?

The FDA product code for First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) is DJR.

Essais cliniques associés

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Autres dossiers indiquant W.H.P.M., Inc. en tant que demandeur

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Dispositifs connexes (Code : DJR)

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Source officielle

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