The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Immunoprep Leukocyte/q-prep Immuno Wrk Sta.
| Device ID | K874188 |
| 510k Number | K874188 |
| Device Name: | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA |
| Classification | Hand-tally, Differential |
| 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 | GKM |
| CFR Regulation Number | 864.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-14 |
| Decision Date | 1988-01-19 |