The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Dhea-sulfate Direct Ria Kit(125i).
| Device ID | K811906 |
| 510k Number | K811906 |
| Device Name: | DHEA-SULFATE DIRECT RIA KIT(125I) |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Applicant | Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-23 |