Device Classification Name |
hsv-1 and hsv-2 cns nucleic-acid based panel
|
510(k) Number |
K141458 |
Device Name |
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK |
Applicant |
FOCUS DIAGNOSTICS |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Applicant Contact |
SHARON YOUNG |
Correspondent |
FOCUS DIAGNOSTICS |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Correspondent Contact |
SHARON YOUNG |
Regulation Number | 866.3307
|
Classification Product Code |
|
Date Received | 06/02/2014 |
Decision Date | 07/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|