The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Channelyzer 256.
Device ID | K851736 |
510k Number | K851736 |
Device Name: | COULTER CHANNELYZER 256 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Contact | & Jone |
Correspondent | & Jone COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-07-30 |