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 | K143573 |
| 510k Number | K143573 |
| Device Name: | Audit MicroControls Linearity FD Tumor Markers II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Contact | Robert Burda |
| Correspondent | Robert Burda AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-17 |
| Decision Date | 2015-01-16 |
| Summary: | summary |