The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Audit Microcv D-dimer Linearity Set, Model K717m-5.
| Device ID | K100716 |
| 510k Number | K100716 |
| Device Name: | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2011-06-23 |
| Summary: | summary |