The following data is part of a premarket notification filed by Medical Specialties Laboratories with the FDA for Uni-cell.
| Device ID | K823587 |
| 510k Number | K823587 |
| Device Name: | UNI-CELL |
| Classification | Mixture, Control, White-cell And Red-cell Indices |
| Applicant | MEDICAL SPECIALTIES LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GLQ |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-06 |
| Decision Date | 1983-01-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNI-CELL 85030124 3959647 Live/Registered |
Huhtamaki, Inc. 2010-05-04 |
![]() UNI-CELL 77066251 3523075 Dead/Cancelled |
CANADIAN ROCKPORT HOMES INTERNATIONAL INC. 2006-12-18 |
![]() UNI-CELL 72411436 0972860 Dead/Expired |
SERVODYNE CORPORATION 1971-12-29 |