The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for System 8000 Cell Counter.
| Device ID | K850386 |
| 510k Number | K850386 |
| Device Name: | SYSTEM 8000 CELL COUNTER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BAKER INSTRUCTIONS CORP. 100 CASCADE DR. P.O. BOX 2168 Allentown, PA 18001 |
| Contact | Tomalesky |
| Correspondent | Tomalesky BAKER INSTRUCTIONS CORP. 100 CASCADE DR. P.O. BOX 2168 Allentown, PA 18001 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-05-02 |