YEAST TRAFFIC LIGHT PNA FISH


Device Classification Name

kit, identification, yeast

510(k) Number K080719
Device Name YEAST TRAFFIC LIGHT 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
JXB  
Date Received 03/13/2008
Decision Date 09/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No