The following data is part of a premarket notification filed by Harleco with the FDA for Cardiozyme Plus Ck-total #65046.
| Device ID | K803169 |
| 510k Number | K803169 |
| Device Name: | CARDIOZYME PLUS CK-TOTAL #65046 |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-15 |
| Decision Date | 1981-01-09 |