The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Virgo (r) Cmv-igg Elisa.
| Device ID | K883102 |
| 510k Number | K883102 |
| Device Name: | VIRGO (R) CMV-IGG ELISA |
| Classification | Antiserum, Cf, Cytomegalovirus |
| Applicant | ELECTRO-NUCLEONICS, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 -1297 |
| Contact | Donna Brandt |
| Correspondent | Donna Brandt ELECTRO-NUCLEONICS, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 -1297 |
| Product Code | GQI |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-22 |
| Decision Date | 1989-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746984 | K883102 | 000 |
| 05391516743402 | K883102 | 000 |