Device Classification Name |
herpes simplex virus nucleic acid amplification assay
|
510(k) Number |
K111951 |
Device Name |
ISOAMP HSV ASSAY |
Applicant |
BIOHELIX CORPORATION |
32 TOZER RD |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
BIOHELIX CORPORATION |
32 TOZER RD |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 07/08/2011 |
Decision Date | 09/27/2011 |
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
|
|
|