The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Cholesterol Reagent Substrate Set.
| Device ID | K781970 |
| 510k Number | K781970 |
| Device Name: | CHOLESTEROL REAGENT SUBSTRATE SET |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-24 |
| Decision Date | 1979-01-03 |