The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Ck-mb Reagent System.
| Device ID | K854708 |
| 510k Number | K854708 |
| Device Name: | DART CK-MB REAGENT SYSTEM |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-22 |
| Decision Date | 1985-12-30 |