The following data is part of a premarket notification filed by Pan Bio Pty. Ltd. with the FDA for Ebv-vca Igg Elisa Test, Model Ebg-100.
| Device ID | K020706 |
| 510k Number | K020706 |
| Device Name: | EBV-VCA IGG ELISA TEST, MODEL EBG-100 |
| Classification | Antiserum, Cf, Epstein-barr Virus |
| Applicant | PAN BIO PTY. LTD. 116 LUTWYCHE RD. Windsor, Brisbane, AU 4030 |
| Contact | Helen Jennings |
| Correspondent | Helen Jennings PAN BIO PTY. LTD. 116 LUTWYCHE RD. Windsor, Brisbane, AU 4030 |
| Product Code | GNP |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2002-06-13 |
| Summary: | summary |