Cleared Traditional

K092236 - E.COLI/P. AERUGINOSA PNA FISH
(FDA 510(k) Clearance)

K092236 · Advandx, Inc. · Microbiology

Dec 2009

Decision

146d

Days

Class 1

Risk

K092236 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 16, 2009, 146 days after receiving the submission on July 23, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K092236 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2009
Decision Date	December 16, 2009
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement