The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Lipase Flex Reagent Cartridge.
| Device ID | K952816 |
| 510k Number | K952816 |
| Device Name: | LIPASE FLEX REAGENT CARTRIDGE |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | DUPONT MEDICAL PRODUCTS BARLEY MILL PLAZA P22-1170 Wilmington, DE 19880 -0022 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DUPONT MEDICAL PRODUCTS BARLEY MILL PLAZA P22-1170 Wilmington, DE 19880 -0022 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1995-07-20 |