FDA 510(k)

Granada Medium

K-Number: K173903 · 2018-03-22

Decision Date2018-03-22

Product CodePQZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Granada Medium is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2018-03-22 under 510(k) number K173903. The device is classified under product code PQZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Granada Medium?

Granada Medium is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Hardy Diagnostics. The 510(k) number is K173903.

When did Granada Medium receive FDA 510(k) clearance?

Granada Medium received FDA 510(k) clearance on 2018-03-22, under 510(k) number K173903.

Who is the listed applicant for Granada Medium?

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

What is the FDA product code for Granada Medium?

The FDA product code for Granada Medium is PQZ.

Other records listing Hardy Diagnostics as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.