The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Dilu-matic 140.
| Device ID | K842446 |
| 510k Number | K842446 |
| Device Name: | DILU-MATIC 140 |
| Classification | Apparatus, Automated Blood Cell Diluting |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-21 |
| Decision Date | 1984-09-06 |