510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861628Substantially Equivalent

Wellcozyme Rotavirus Wz01

Wellcome Diagnostics, Research Triangle Pk NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861628 is the FDA 510(k) clearance record for WELLCOZYME ROTAVIRUS WZ01, a class I device, cleared for Wellcome Diagnostics on under FDA product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus). FDA records list 28 510(k) clearances for Wellcome Diagnostics, from to . As of , FDA records show no recalls naming K861628.

Clearance record

Decision date
Received
(267 days to decision)
Product code
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Applicant
Wellcome Diagnostics 3030 Cornwallis Rd., Research Triangle Pk NC
Third party review
No

Clearances, product code LIQ

Trailing 12 months

FDA records hold no clearances under product code LIQ in the trailing twelve months.

FDA records show no clearances under product code LIQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260