Cleared Traditional

GRAM-NEGATIVE QUICKFISH BC

K123418 · Advandx, Inc. · Microbiology
Jul 2013
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K123418 is an FDA 510(k) clearance for the GRAM-NEGATIVE QUICKFISH BC, a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on July 21, 2013, 257 days after receiving the submission on November 6, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K123418 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2012
Decision Date July 21, 2013
Days to Decision 257 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JSS — Kit, Identification, Enterobacteriaceae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660