Cleared Traditional

Remel Spectra ESBL

K162620 · Remel, Inc. · Microbiology
May 2017
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K162620 is an FDA 510(k) clearance for the Remel Spectra ESBL, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on May 1, 2017, 223 days after receiving the submission on September 20, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K162620 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2016
Decision Date May 01, 2017
Days to Decision 223 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1700