510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945538Substantially Equivalent

Staphaurex Plus(tm)

Murex Diagnostics Limitd, England, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945538 is the FDA 510(k) clearance record for STAPHAUREX PLUS(TM), a class I device, cleared for Murex Diagnostics Limitd on under FDA product code JWX (Kit, Screening, Staphylococcus Aureus). FDA records list one 510(k) clearance for Murex Diagnostics Limitd. As of , FDA records show no recalls naming K945538.

Clearance record

Decision date
Received
(199 days to decision)
Product code
JWX Kit, Screening, Staphylococcus Aureus
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Murex Diagnostics Limitd Central Rd., Temple Hill, England, DE
510(k) summary
Summary
Third party review
No

Clearances, product code JWX

Trailing 12 months

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

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