The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Hemo-w System.
| Device ID | K781628 |
| 510k Number | K781628 |
| Device Name: | HEMO-W SYSTEM |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-25 |
| Decision Date | 1978-10-27 |