The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Virgo(tm) Rubella Igg Elisa.
| Device ID | K873088 |
| 510k Number | K873088 |
| Device Name: | VIRGO(TM) RUBELLA IGG ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | Labrec, Phd |
| Correspondent | Labrec, Phd ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-05 |
| Decision Date | 1987-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747004 | K873088 | 000 |
| 05391516743433 | K873088 | 000 |
| 05391516746786 | K873088 | 000 |
| 05391516746748 | K873088 | 000 |
| 05391516746878 | K873088 | 000 |
| 05391516746533 | K873088 | 000 |
| 05391516746526 | K873088 | 000 |
| 05391516746519 | K873088 | 000 |