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 |