The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Multi-q-prep.
| Device ID | K923530 |
| 510k Number | K923530 |
| Device Name: | COULTER MULTI-Q-PREP |
| Classification | Apparatus, Automated Blood Cell Diluting |
| 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 | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1992-10-14 |