The following data is part of a premarket notification filed by Worthington Diagnostic Systems with the FDA for Worthington Flozyme* Cpk (340nm).
| Device ID | K800028 |
| 510k Number | K800028 |
| Device Name: | WORTHINGTON FLOZYME* CPK (340NM) |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | WORTHINGTON DIAGNOSTIC SYSTEMS 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 | 1980-01-07 |
| Decision Date | 1980-01-21 |