EK/P. AERUGINOSA PNA FISH


Device Classification Name

kit, identification, enterobacteriaceae

510(k) Number K081433
Device Name EK/P. AERUGINOSA PNA FISH
Applicant
ADVANDX, INC.
10a roessler road
woburn, 
MA 
01801

Applicant Contact henrik stender
Correspondent
ADVANDX, INC.
10a roessler road
woburn, 
MA 
01801

Correspodent Contact henrik stender
Regulation Number 866.2660
Classification Product Code
JSS  
Date Received 05/21/2008
Decision Date 03/26/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No