The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Virgo(r) Vzv-igg Elisa.
| Device ID | K883427 |
| 510k Number | K883427 |
| Device Name: | VIRGO(R) VZV-IGG ELISA |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1989-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747066 | K883427 | 000 |
| 05391516743525 | K883427 | 000 |