Cleared Traditional

YEAST TRAFFIC LIGHT PNA FISH

K080719 · Advandx, Inc. · Microbiology

Sep 2008

Decision

183d

Days

Class 1

Risk

About This 510(k) Submission

K080719 is an FDA 510(k) clearance for the YEAST TRAFFIC LIGHT PNA FISH, a Kit, Identification, Yeast (Class I — General Controls, product code JXB), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on September 12, 2008, 183 days after receiving the submission on March 13, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K080719 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2008
Decision Date	September 12, 2008
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement