The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv Homocysteine Linearity Set, Model 704m-5.
| Device ID | K100715 |
| 510k Number | K100715 |
| Device Name: | AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Contact | Brandon J Perez |
| Correspondent | Brandon J Perez AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. Carlsbad, CA 92008 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-12-23 |
| Summary: | summary |