The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Transphor.
| Device ID | K800544 |
| 510k Number | K800544 |
| Device Name: | CORNING TRANSPHOR |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-10 |
| Decision Date | 1980-03-20 |