Cleared Traditional

K173903 - Granada Medium

K173903 is an FDA 510(k) clearance for Granada Medium, manufactured by Hardy Diagnostics. The device is a Class 1 Microbiology device with product code PQZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K173903 is an FDA 510(k) clearance for the Granada Medium. Classified as Gbs Culture Media, Selective And Differential (product code PQZ), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on March 22, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hardy Diagnostics devices

FDA 510(k) Submission Details - K173903

510(k) Number K173903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

PQZ Device Classification - Class 1, General Controls

Product Code PQZ Gbs Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
Definition Culture Medium For Gbs Detection
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.