Cleared Traditional

Strep B Carrot Broth Kit

K170481 · Hardy Diagnostics · Microbiology
May 2017
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K170481 is an FDA 510(k) clearance for the Strep B Carrot Broth Kit, 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 May 16, 2017, 89 days after receiving the submission on February 16, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K170481 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2017
Decision Date May 16, 2017
Days to Decision 89 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