The following data is part of a premarket notification filed by Abx, Inc. with the FDA for Minos Automatic Cell Counter.
Device ID | K880616 |
510k Number | K880616 |
Device Name: | MINOS AUTOMATIC CELL COUNTER |
Classification | Counter, Differential Cell |
Applicant | ABX, INC. 355 BUSINESS CENTER DR. Horsham, PA 19044 |
Contact | William M Dougherty |
Correspondent | William M Dougherty ABX, INC. 355 BUSINESS CENTER DR. Horsham, PA 19044 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-16 |
Decision Date | 1988-05-02 |