The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Modified Labeling For Aca Lipase Analytical Test.
| Device ID | K901858 |
| 510k Number | K901858 |
| Device Name: | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Contact | Christopher Bentsen |
| Correspondent | Christopher Bentsen E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Product Code | CET |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-06-12 |