The following data is part of a premarket notification filed by Trinity Biotech, Inc. with the FDA for Rotavirus Eia.
| Device ID | K964424 |
| 510k Number | K964424 |
| Device Name: | ROTAVIRUS EIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | TRINITY BIOTECH, INC. 3722 AVE. SAUSALILO Irvine, CA 92606 -1849 |
| Contact | Grace Holland |
| Correspondent | Grace Holland TRINITY BIOTECH, INC. 3722 AVE. SAUSALILO Irvine, CA 92606 -1849 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-05 |
| Decision Date | 1997-08-08 |