The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Lpia-ferritin Assay.
| Device ID | K924186 |
| 510k Number | K924186 |
| Device Name: | LPIA-FERRITIN ASSAY |
| Classification | Alpha-2-hs-glycoprotein, Antigen, Antiserum, Control |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Andris Indriksons |
| Correspondent | Andris Indriksons SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | DEF |
| CFR Regulation Number | 866.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1992-12-23 |