FDA 510(k)

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

Numéro K : K180349 · 2018-04-05

DemandeurAssure Tech. (Hangzhou) Co, Ltd.

Date de décision2018-04-05

Code produitNFT

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180349. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K180349.

When did AssureTech Panel Dip Tests, AssureTech Quick Cup Tests receive FDA 510(k) clearance?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180349.

Who is the listed applicant for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

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

What is the FDA product code for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

The FDA product code for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is NFT.

Essais cliniques associés

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Source officielle

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