Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K163629 |
Device Name |
Audit MicroControls Linearity FD Tumor Markers II |
Applicant |
Aalto Scientific, Ltd. |
230 Technology Parkway |
Eatonton,
GA
31024
|
|
Applicant Contact |
Robert Burda |
Correspondent |
Aalto Scientific, Ltd. |
230 Technology Parkway |
Eatonton,
GA
31024
|
|
Correspondent Contact |
Robert Burda |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/22/2016 |
Decision Date | 03/10/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|