The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for The Wellcome Rotavirus Latex Test Zl40.
| Device ID | K861634 |
| 510k Number | K861634 |
| Device Name: | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Max D Moodly |
| Correspondent | Max D Moodly 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 | 1986-10-29 |