510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031952Substantially Equivalent

West Nile Virus Igm Capture Elisa, Model El0300m

Focus Technologies, Inc., Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031952 is the FDA 510(k) clearance record for WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M, a class II device, cleared for Focus Technologies, Inc. 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 5 510(k) clearances for Focus Technologies, Inc., from to . As of , FDA records show no recalls naming K031952.

Clearance record

Decision date
Received
(119 days to decision)
Product code
NOP Elisa, Antibody, West Nile Virus
Regulation
21 CFR 866.3940
Device class
Class II
Review panel
Microbiology
Applicant
Focus Technologies, Inc. 10703 Progress Way, Cypress CA
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