Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K152117 |
Device Name |
Dropper hsCRP High Sensitivity CRP Control |
Applicant |
Quantimetrix Corporation |
2005 Manhattan Beach Blvd |
Redondo Beach,
CA
90278
|
|
Applicant Contact |
Kaylna Snylyk |
Correspondent |
Quantimetrix Corporation |
2005 Manhattan Beach Blvd |
Redondo Beach,
CA
90278
|
|
Correspondent Contact |
Kaylna Snylyk |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 07/30/2015 |
Decision Date | 04/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|