The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Aca(r) Urine Druge Os Abuse Control.
| Device ID | K952412 |
| 510k Number | K952412 |
| Device Name: | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | DUPONT MEDICAL PRODUCTS BUILDING 500 , MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DUPONT MEDICAL PRODUCTS BUILDING 500 , MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-23 |
| Decision Date | 1995-06-23 |