Cleared Traditional

Strep B Carrot Broth One-Step

K170586 · Hardy Diagnostics · Microbiology
May 2017
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K170586 is an FDA 510(k) clearance for the Strep B Carrot Broth One-Step, 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 22, 2017, 83 days after receiving the submission on February 28, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K170586 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2017
Decision Date May 22, 2017
Days to Decision 83 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