Device Classification Name |
herpes simplex virus nucleic acid amplification assay
|
510(k) Number |
K140029 |
Device Name |
AMIPLIVUE HSV 1&2 ASSAY |
Applicant |
QUIDEL CORPORATION |
10165 MCKELLAR COURT |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Ronald H Lollar |
Correspondent |
QUIDEL CORPORATION |
10165 MCKELLAR COURT |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
Ronald H Lollar |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 01/06/2014 |
Decision Date | 03/26/2014 |
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
|
|
|