Cleared Traditional

K081433 - EK/P. AERUGINOSA PNA FISH
(FDA 510(k) Clearance)

K081433 · Advandx, Inc. · Microbiology device

Mar 2009

Decision

309d

Days

Class 1

Risk

K081433 is an FDA 510(k) clearance for the EK/P. AERUGINOSA PNA FISH. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).

Submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on March 26, 2009, 309 days after receiving the submission on May 21, 2008.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K081433 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 21, 2008
Decision Date	March 26, 2009
Days to Decision	309 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement