Cleared Traditional

chromID Strepto B agar

K163042 · bioMerieux, Inc. · Microbiology
Jan 2017
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K163042 is an FDA 510(k) clearance for the chromID Strepto B agar, a Gbs Culture Media, Selective And Differential (Class I — General Controls, product code PQZ), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on January 27, 2017, 88 days after receiving the submission on October 31, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K163042 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2016
Decision Date January 27, 2017
Days to Decision 88 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