The following data is part of a premarket notification filed by Logos Scientific, Inc. with the FDA for Elvi 828 Digiclot Multiscan.
| Device ID | K902614 |
| 510k Number | K902614 |
| Device Name: | ELVI 828 DIGICLOT MULTISCAN |
| Classification | Instrument, Coagulation |
| Applicant | LOGOS SCIENTIFIC, INC. 700 SUNSET RD. Henderson, NV 89015 |
| Contact | Ej Bechtel |
| Correspondent | Ej Bechtel LOGOS SCIENTIFIC, INC. 700 SUNSET RD. Henderson, NV 89015 |
| Product Code | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-13 |
| Decision Date | 1990-11-08 |