The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Sr-plus Direct Cholesterol Test.
| Device ID | K780545 |
| 510k Number | K780545 |
| Device Name: | SR-PLUS DIRECT CHOLESTEROL TEST |
| Classification | Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGO |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-03 |
| Decision Date | 1978-05-26 |