The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca(r) Urine Phencyclidine (u Pcp) Screen Method.
| Device ID | K911725 |
| 510k Number | K911725 |
| Device Name: | ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-17 |
| Decision Date | 1991-06-03 |