Device Classification Name |
clinical sample concentrator
|
510(k) Number |
K113731 |
Device Name |
ESENSOR RESPIRATORY VIRAL PANEL |
Applicant |
CLINICAL MICRO SENSORS, INC. |
5964 LA PLACE COURT |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
JOEL CENTENO |
Correspondent |
CLINICAL MICRO SENSORS, INC. |
5964 LA PLACE COURT |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
JOEL CENTENO |
Regulation Number | 862.2310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2011 |
Decision Date | 09/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|