The following data is part of a premarket notification filed by Abx, Inc. with the FDA for Minos Automatic Cell Counter.
| Device ID | K864579 |
| 510k Number | K864579 |
| Device Name: | MINOS AUTOMATIC CELL COUNTER |
| Classification | Counter, Differential Cell |
| Applicant | ABX, INC. R.D. #3 BOX 416 Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke ABX, INC. R.D. #3 BOX 416 Ringoes, NJ 08551 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-20 |
| Decision Date | 1987-07-16 |