The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Cholesterol Standards.
| Device ID | K802823 |
| 510k Number | K802823 |
| Device Name: | CHOLESTEROL STANDARDS |
| Classification | Calibrator, Secondary |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-10 |
| Decision Date | 1980-12-11 |