Cleared Traditional

K092393 - EK/P. AERUGINOSA PNA FISH
(FDA 510(k) Clearance)

K092393 · Advandx, Inc. · Microbiology
Sep 2009
Decision
27d
Days
Class 1
Risk

K092393 is an FDA 510(k) clearance for the EK/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 September 1, 2009, 27 days after receiving the submission on August 5, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K092393 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2009
Decision Date September 01, 2009
Days to Decision 27 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