The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Profile 750 Blood Cell Counter.
| Device ID | K823886 |
| 510k Number | K823886 |
| Device Name: | PROFILE 750 BLOOD CELL COUNTER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-27 |
| Decision Date | 1983-03-01 |