The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Isoenzyme Serum Control.
| Device ID | K780147 |
| 510k Number | K780147 |
| Device Name: | ISOENZYME SERUM CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | CORNING MEDICAL & SCIENTIFIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-30 |
| Decision Date | 1978-02-23 |