The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Ck-mb Isoenzyme Reagent.
| Device ID | K904866 |
| 510k Number | K904866 |
| Device Name: | COULTER CK-MB ISOENZYME REAGENT |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| 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 | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-29 |
| Decision Date | 1990-12-13 |