The following data is part of a premarket notification filed by Bioscientific with the FDA for White Blood Cell Count Control Levels.
| Device ID | K801265 |
| 510k Number | K801265 |
| Device Name: | WHITE BLOOD CELL COUNT CONTROL LEVELS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | BIOSCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-07-14 |