FDA 510(k)

Scanostics UTI Check Application Test System

Numéro K : K170118 · 2017-09-21

Date de décision2017-09-21

Code produitJMT

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Scanostics UTI Check Application Test System is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K170118. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Scanostics UTI Check Application Test System?

Scanostics UTI Check Application Test System is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Teco Diagnostics. The 510(k) number is K170118.

When did Scanostics UTI Check Application Test System receive FDA 510(k) clearance?

Scanostics UTI Check Application Test System received FDA 510(k) clearance on 2017-09-21, under 510(k) number K170118.

Who is the listed applicant for Scanostics UTI Check Application Test System?

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

What is the FDA product code for Scanostics UTI Check Application Test System?

The FDA product code for Scanostics UTI Check Application Test System is JMT.

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Dispositifs connexes (Code : JMT)

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Source officielle

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