Device Classification Name |
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
|
510(k) Number |
K082612 |
Device Name |
GBS PNA FISH |
Applicant |
ADVANDX, INC. |
10A ROESSLER ROAD |
WOBURN,
MA
01801
|
|
Applicant Contact |
PAULA E BULGER |
Correspondent |
ADVANDX, INC. |
10A ROESSLER ROAD |
WOBURN,
MA
01801
|
|
Correspondent Contact |
PAULA E BULGER |
Regulation Number | 866.3740
|
Classification Product Code |
|
Date Received | 09/09/2008 |
Decision Date | 05/05/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|