The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv Immunoassay Linearity Set.
| Device ID | K062668 |
| 510k Number | K062668 |
| Device Name: | AUDIT MICROCV IMMUNOASSAY LINEARITY SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Contact | Alan Vekich |
| Correspondent | Alan Vekich 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 | 2006-09-08 |
| Decision Date | 2006-10-16 |
| Summary: | summary |