The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv General Chemistry Linearity Set.
| Device ID | K042318 |
| 510k Number | K042318 |
| Device Name: | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Contact | Alan J Vekich |
| Correspondent | Alan J 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 | 2004-08-26 |
| Decision Date | 2004-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014153 | K042318 | 000 |
| 00811727014146 | K042318 | 000 |
| 00811727010735 | K042318 | 000 |
| 00811727010728 | K042318 | 000 |
| 00811727010711 | K042318 | 000 |