The following data is part of a premarket notification filed by Pan Bio Pty. Ltd. with the FDA for Ebv Ea-d Igg Elisa Kit, Model Ebg-100.
| Device ID | K021793 |
| 510k Number | K021793 |
| Device Name: | EBV EA-D IGG ELISA KIT, MODEL EBG-100 |
| Classification | Epstein-barr Virus, Other |
| Applicant | PAN BIO PTY. LTD. 116 LUTWYCHE RD. WINDSOR Brisbane, Queensland, AU 4030 |
| Contact | Helen Jennings |
| Correspondent | Helen Jennings PAN BIO PTY. LTD. 116 LUTWYCHE RD. WINDSOR Brisbane, Queensland, AU 4030 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-31 |
| Decision Date | 2002-09-27 |
| Summary: | summary |