The following data is part of a premarket notification filed by Sienna Biotech, Inc. with the FDA for Copalis Cmv Total Antibody Assay.
| Device ID | K955799 |
| 510k Number | K955799 |
| Device Name: | COPALIS CMV TOTAL ANTIBODY ASSAY |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | SIENNA BIOTECH, INC. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Contact | Joyce T David |
| Correspondent | Joyce T David SIENNA BIOTECH, INC. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-07-10 |
| Summary: | summary |