The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Counter Model T Series W/2-part Different..
Device ID | K874838 |
510k Number | K874838 |
Device Name: | COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. |
Classification | Counter, Differential Cell |
Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Contact | Richardson-jones |
Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-24 |
Decision Date | 1988-02-19 |