The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Flow Reticulocyte Reagent.
| Device ID | K885332 |
| 510k Number | K885332 |
| Device Name: | COULTER FLOW RETICULOCYTE REAGENT |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | A Richardson-jones |
| Correspondent | A Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-02-22 |