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 |