The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Counter Model M5.
| Device ID | K853429 |
| 510k Number | K853429 |
| Device Name: | COULTER COUNTER MODEL M5 |
| 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 | 1985-08-15 |
| Decision Date | 1985-10-10 |