The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Lipase Reagent.
| Device ID | K862440 |
| 510k Number | K862440 |
| Device Name: | PARAMAX LIPASE REAGENT |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Krista L Underwood |
| Correspondent | Krista L Underwood AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | CET |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-08-04 |