Cleared Traditional

E.COLI/P. AERUGINOSA PNA FISH

K081309 · Advandx, Inc. · Microbiology

Dec 2008

Decision

224d

Days

Class 1

Risk

About This 510(k) Submission

K081309 is an FDA 510(k) clearance for the E.COLI/P. AERUGINOSA 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 19, 2008, 224 days after receiving the submission on May 9, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K081309 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2008
Decision Date	December 19, 2008
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement