The following data is part of a premarket notification filed by American Dade with the FDA for Smi Digitron.
| Device ID | K870406 |
| 510k Number | K870406 |
| Device Name: | SMI DIGITRON |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-02-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SMI DIGITRON 73512017 1347481 Dead/Cancelled |
AMERICAN HOSPITAL SUPPLY CORPORATION 1984-12-04 |