The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Diff3 Sys. (coulter #7400003).
| Device ID | K791903 |
| 510k Number | K791903 |
| Device Name: | COULTER DIFF3 SYS. (COULTER #7400003) |
| Classification | Counter, Differential Cell |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-10-30 |