The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Morphine Roche (r) Eia Test.
| Device ID | K864168 |
| 510k Number | K864168 |
| Device Name: | MORPHINE ROCHE (R) EIA TEST |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Contact | Griffin Fitzgerald |
| Correspondent | Griffin Fitzgerald ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Product Code | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-24 |
| Decision Date | 1987-03-16 |