Cleared Traditional

E. COLI PNA FISH

K082068 · Advandx, Inc. · Microbiology
Jun 2009
Decision
338d
Days
Class 1
Risk

About This 510(k) Submission

K082068 is an FDA 510(k) clearance for the E. COLI 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 June 25, 2009, 338 days after receiving the submission on July 22, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K082068 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2008
Decision Date June 25, 2009
Days to Decision 338 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