The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Px Coulter(r) Cell Control.
| Device ID | K912133 |
| 510k Number | K912133 |
| Device Name: | PX COULTER(R) CELL CONTROL |
| Classification | Mixture, Hematology Quality Control |
| 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 | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-07-17 |