510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041231Substantially Equivalent

West Nile Virus Igm Capture Elisa, Model E-Wnv02m

Panbio Limited, Windsor, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041231 is the FDA 510(k) clearance record for WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M, a class II device, cleared for Panbio Limited on under FDA product code NOP (Elisa, Antibody, West Nile Virus). FDA's definition for product code NOP reads: "The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients". FDA records list 8 510(k) clearances for Panbio Limited, from to . As of , FDA records show one recall naming K041231.

Clearance record

Decision date
Received
(92 days to decision)
Product code
NOP Elisa, Antibody, West Nile Virus
Regulation
21 CFR 866.3940
Device class
Class II
Review panel
Microbiology
Applicant
Panbio Limited 116 Lutwyche Rd., Windsor, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOP

Trailing 12 months

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

FDA records show no clearances under product code NOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOP, 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