The following data is part of a premarket notification filed by Sienna Biotech, Inc. with the FDA for Copalis One Immunoassay System/toxoplasma Gondii/rubella/cmv Total Antibody Assays.
| Device ID | K961784 |
| 510k Number | K961784 |
| Device Name: | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS |
| 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 | 1996-05-02 |
| Decision Date | 1996-10-31 |
| Summary: | summary |