The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Epstein-barr Virus Ebna-igg Antibody Elisa Test.
Device ID | K911569 |
510k Number | K911569 |
Device Name: | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST |
Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
Contact | Kim W Gray |
Correspondent | Kim W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
Product Code | LLM |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-08 |
Decision Date | 1991-06-10 |