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 |