The following data is part of a premarket notification filed by Sienna Biotech, Inc. with the FDA for Copalis Torc Total Antibody Assay.
| Device ID | K970931 |
| 510k Number | K970931 |
| Device Name: | COPALIS TORC TOTAL ANTIBODY ASSAY |
| Classification | Latex Agglutination Assay, Rubella |
| Applicant | SIENNA BIOTECH, INC. 9115 GUILFORD RD. SUITE 180 Columbia, MD 21046 -1893 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith SIENNA BIOTECH, INC. 9115 GUILFORD RD. SUITE 180 Columbia, MD 21046 -1893 |
| Product Code | LQN |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-04-24 |
| Summary: | summary |