| Device Classification Name |
enzyme immunoassay, opiates
|
| 510(k) Number | K872391 |
| Device Name | ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD |
| Applicant |
| E.I. DUPONT DE NEMOURS & CO., INC. |
medical products department |
barley mill plaza, p22-1170 |
wilmington,
DE
19898 |
|
| Contact | grace h singles |
| Regulation Number | 862.3650 |
| Classification Product Code |
|
| Date Received | 06/19/1987 |
| Decision Date | 08/10/1987 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Toxicology
|
| Review Advisory Committee |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
|
|
|