The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcozyme Rotavirus Wz01.
| Device ID | K861628 |
| 510k Number | K861628 |
| Device Name: | WELLCOZYME ROTAVIRUS WZ01 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Moody, Ph.d. |
| Correspondent | Moody, Ph.d. WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1987-01-21 |