The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Virgo(tm) Measles Igg Elisa.
| Device ID | K873925 |
| 510k Number | K873925 |
| Device Name: | VIRGO(TM) MEASLES IGG ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | Labrec, Ph.d. |
| Correspondent | Labrec, Ph.d. ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | LJB |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-25 |
| Decision Date | 1988-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747127 | K873925 | 000 |
| 05391516743631 | K873925 | 000 |