The following data is part of a premarket notification filed by Pharmacia Diagnostics, Inc. with the FDA for Ebv-vca Igm Elisa.
| Device ID | K915348 |
| 510k Number | K915348 |
| Device Name: | EBV-VCA IGM ELISA |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| Applicant | PHARMACIA DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Steven Vinson |
| Correspondent | Steven Vinson PHARMACIA DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-02-14 |