The following data is part of a premarket notification filed by Electrophoresis Corp. with the FDA for Cpk Isoenzyme Substrate.
| Device ID | K790309 |
| 510k Number | K790309 |
| Device Name: | CPK ISOENZYME SUBSTRATE |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | ELECTROPHORESIS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-13 |
| Decision Date | 1979-04-04 |