Device Classification Name |
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
|
510(k) Number |
K083074 |
Device Name |
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT |
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 | 10/15/2008 |
Decision Date | 07/24/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|