The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Cell-dyn Brand Hematology Reagents.
| Device ID | K852372 |
| 510k Number | K852372 |
| Device Name: | CELL-DYN BRAND HEMATOLOGY REAGENTS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Contact | Ruth M Becker |
| Correspondent | Ruth M Becker ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-04 |
| Decision Date | 1985-09-03 |