Cleared Traditional

GNR TRAFFIC LIGHT PNA FISH

K101558 · Advandx, Inc. · Microbiology
Dec 2010
Decision
195d
Days
Class 1
Risk

About This 510(k) Submission

K101558 is an FDA 510(k) clearance for the GNR TRAFFIC LIGHT PNA FISH, a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on December 16, 2010, 195 days after receiving the submission on June 4, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K101558 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2010
Decision Date December 16, 2010
Days to Decision 195 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