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
|
|
Correspondent Contact |
HENRIK STENDER |
Regulation Number | 866.2660
|
Classification Product Code |
|
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
|
|
|