The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for 25-hydroxyvitamin D 125i Ria Kit.
| Device ID | K983617 |
| 510k Number | K983617 |
| Device Name: | 25-HYDROXYVITAMIN D 125I RIA KIT |
| Classification | Automated Radioimmunoassay Systems, For Clinical Use |
| Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Product Code | LCI |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1998-11-16 |
| Summary: | summary |