The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Quick-count.
| Device ID | K833971 |
| 510k Number | K833971 |
| Device Name: | QUICK-COUNT |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | SERAGEN DIAGNOSTICS, 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 | 1983-11-16 |
| Decision Date | 1984-01-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QUICK-COUNT 73460215 not registered Dead/Abandoned |
SERAGEN DIAGNOSTICS, INC. 1984-01-09 |
![]() QUICK-COUNT 73395832 1315905 Live/Registered |
W. T. Rogers Co. 1982-09-30 |