Cleared Traditional

Granada Medium

K173903 · Hardy Diagnostics · Microbiology
Mar 2018
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K173903 is an FDA 510(k) clearance for the Granada Medium, a Gbs Culture Media, Selective And Differential (Class I — General Controls, product code PQZ), submitted by Hardy Diagnostics (Santa Monica, US). The FDA issued a Cleared decision on March 22, 2018, 90 days after receiving the submission on December 22, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K173903 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2017
Decision Date March 22, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PQZ — Gbs Culture Media, Selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360
Definition Culture Medium For Gbs Detection