The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Lipase Calibrator.
| Device ID | K952815 |
| 510k Number | K952815 |
| Device Name: | DUPONT LIPASE CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DUPONT MEDICAL PRODUCTS BUILDING 500 , MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DUPONT MEDICAL PRODUCTS BUILDING 500 , MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1995-08-31 |