The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Ige Radioimmunoassay Kit.
| Device ID | K831377 |
| 510k Number | K831377 |
| Device Name: | IGE RADIOIMMUNOASSAY KIT |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | AMERICAN DIAGNOSTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-27 |
| Decision Date | 1983-06-02 |