The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for System 9000 Diff Model Automated Cell Counter.
| Device ID | K882612 |
| 510k Number | K882612 |
| Device Name: | SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER |
| Classification | Counter, Differential Cell |
| Applicant | BAKER INSTRUCTIONS CORP. 3085 SHAWNEE DR. P.O. BOX 2867 Winchester, VA 22601 |
| Contact | Tomalesky |
| Correspondent | Tomalesky BAKER INSTRUCTIONS CORP. 3085 SHAWNEE DR. P.O. BOX 2867 Winchester, VA 22601 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1988-09-07 |