The following data is part of a premarket notification filed by Electrophoresis Corp. Of America with the FDA for Cpk Isoenzyme Control.
| Device ID | K791299 |
| 510k Number | K791299 |
| Device Name: | CPK ISOENZYME CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | ELECTROPHORESIS CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-16 |
| Decision Date | 1979-08-16 |