The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Copalis Treponemal Antigen Total Antibody Assay.
| Device ID | K992552 |
| 510k Number | K992552 |
| Device Name: | COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-12-16 |
| Summary: | summary |