The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Mh009.
| Device ID | K922181 |
| 510k Number | K922181 |
| Device Name: | COULTER MH009 |
| 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 | 1992-05-08 |
| Decision Date | 1992-08-17 |