Device Classification Name |
Herpes Simplex Virus Nucleic Acid Amplification Assay
|
510(k) Number |
K100336 |
Device Name |
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 |
Applicant |
ERAGEN BIOSCIENCES |
918 DEMING WAY SUITE 201 |
MADISON,
WI
53717
|
|
Applicant Contact |
RANDAL VADER |
Correspondent |
ERAGEN BIOSCIENCES |
918 DEMING WAY SUITE 201 |
MADISON,
WI
53717
|
|
Correspondent Contact |
RANDAL VADER |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 02/05/2010 |
Decision Date | 05/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|