The following data is part of a premarket notification filed by Aalto Scientific, Ltd. with the FDA for Audit Microcontrols Linearity Fd Tumor Markers Ii.
| Device ID | K163629 |
| 510k Number | K163629 |
| Device Name: | Audit MicroControls Linearity FD Tumor Markers II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Aalto Scientific, Ltd. 230 Technology Parkway Eatonton, GA 31024 |
| Contact | Robert Burda |
| Correspondent | Robert Burda Aalto Scientific, Ltd. 230 Technology Parkway Eatonton, GA 31024 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-03-10 |
| Summary: | summary |