The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Triglycerides Test Kit.
| Device ID | K781477 |
| 510k Number | K781477 |
| Device Name: | TRIGLYCERIDES TEST KIT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-10-03 |