The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemeni Igm Assay.
| Device ID | K800450 |
| 510k Number | K800450 |
| Device Name: | GEMENI IGM ASSAY |
| Classification | Igm (mu Chain Specific), Antigen, Antiserum, Control |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DAO |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-29 |
| Decision Date | 1980-04-24 |