The following data is part of a premarket notification filed by Mrl Diagnostics with the FDA for Epstein-barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay.
| Device ID | K946353 |
| 510k Number | K946353 |
| Device Name: | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Contact | Bill Hyatt |
| Correspondent | Bill Hyatt MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-30 |
| Decision Date | 1995-07-21 |