The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Cell-dyn 4000 Immunopit (cd61) Assay.
| Device ID | K981342 |
| 510k Number | K981342 |
| Device Name: | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY |
| Classification | Counter, Differential Cell |
| Applicant | ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Contact | Janice E Brown |
| Correspondent | Janice E Brown ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-06-29 |
| Summary: | summary |