Device Classification Name |
herpes simplex virus nucleic acid amplification assay
|
510(k) Number |
K111527 |
Device Name |
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT |
Applicant |
ERAGEN BIOSCIENCES, INC. |
918 Deming Way, Suite 201 |
Madison,
WI
53717 -1944
|
|
Applicant Contact |
DAVID LIM |
Correspondent |
ERAGEN BIOSCIENCES, INC. |
918 Deming Way, Suite 201 |
Madison,
WI
53717 -1944
|
|
Correspondent Contact |
DAVID LIM |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 06/01/2011 |
Decision Date | 08/03/2011 |
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
|
|
|