FDA 510(k)

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

Numéro K : K153646 · 2016-03-18

DemandeurSafecare Biotech (Hangzhou) Co., Ltd.

Date de décision2016-03-18

Code produitDIO

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K153646. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K153646.

When did SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana receive FDA 510(k) clearance?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana received FDA 510(k) clearance on 2016-03-18, under 510(k) number K153646.

Who is the listed applicant for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

The FDA 510(k) record lists Safecare Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

The FDA product code for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is DIO.

Essais cliniques associés

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Source officielle

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