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 |