The following data is part of a premarket notification filed by Harleco with the FDA for Cardiozyme Plus Ck-total Item #65046 (a).
| Device ID | K811576 |
| 510k Number | K811576 |
| Device Name: | CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-04 |
| Decision Date | 1981-06-25 |