The following data is part of a premarket notification filed by Icn Immunobiologicals with the FDA for Accraassay Rid Kits.
| Device ID | K882369 |
| 510k Number | K882369 |
| Device Name: | ACCRAASSAY RID KITS |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | ICN IMMUNOBIOLOGICALS P.O. BOX 1200 Lisle, IL 60532 |
| Contact | L. G Sudbury |
| Correspondent | L. G Sudbury ICN IMMUNOBIOLOGICALS P.O. BOX 1200 Lisle, IL 60532 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-08 |
| Decision Date | 1988-07-12 |