The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Copalis Ebv-m Antibody Assay.
| Device ID | K991459 |
| 510k Number | K991459 |
| Device Name: | COPALIS EBV-M ANTIBODY ASSAY |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Product Code | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-05-14 |
| Summary: | summary |