The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv Therapeutic Drug (tdm) Linearity Set.
| Device ID | K130762 |
| 510k Number | K130762 |
| Device Name: | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Contact | Dessi Lyakov |
| Correspondent | Dessi Lyakov 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 | 2013-03-20 |
| Decision Date | 2013-04-29 |
| Summary: | summary |