Device Classification Name |
Herpes Simplex Virus Nucleic Acid Amplification Assay
|
510(k) Number |
K142156 |
Device Name |
SEEGENE ANYPLEX II HSV-1/2 ASSAY |
Applicant |
SEEGENE |
180 Cabot Street |
Beverly,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
MDC ASSOCIATES, LLC |
180 Cabot Street |
Beverly,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 08/06/2014 |
Decision Date | 02/13/2015 |
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
|
|
|