The following data is part of a premarket notification filed by Icn Micromedic Systems with the FDA for Micromedic Morphine Ria Kit.
| Device ID | K881102 |
| 510k Number | K881102 |
| Device Name: | MICROMEDIC MORPHINE RIA KIT |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Applicant | ICN MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Contact | Debra L Mansfield |
| Correspondent | Debra L Mansfield ICN MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Product Code | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-15 |
| Decision Date | 1988-06-24 |