The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Lipase Test Kit.
| Device ID | K792289 |
| 510k Number | K792289 |
| Device Name: | LIPASE TEST KIT |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CET |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-13 |
| Decision Date | 1979-12-18 |