The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Abuscreen Radioummunoassay--urine.
| Device ID | K830462 |
| 510k Number | K830462 |
| Device Name: | ABUSCREEN RADIOUMMUNOASSAY--URINE |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-03-24 |