The following data is part of a premarket notification filed by Genbio with the FDA for Immunowell Vca Igm Test.
Device ID | K973939 |
510k Number | K973939 |
Device Name: | IMMUNOWELL VCA IGM TEST |
Classification | Antibody Igm, If, Epstein-barr Virus |
Applicant | GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
Contact | Bryan Kiehl |
Correspondent | Bryan Kiehl GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
Product Code | LJN |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-15 |
Decision Date | 1998-08-10 |
Summary: | summary |