The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Counter Model S Plus Junior.
Device ID | K861780 |
510k Number | K861780 |
Device Name: | COULTER COUNTER MODEL S PLUS JUNIOR |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Contact | Richardson-jones |
Correspondent | Richardson-jones 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 | 1986-05-08 |
Decision Date | 1986-08-06 |