510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203245Substantially Equivalent

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

Nucleix Ltd., Rehovot, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203245 is the FDA 510(k) clearance record for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C, a class II device, cleared for Nucleix , Ltd. on under FDA product code MMW (System, Test, Tumor Marker, Monitoring, Bladder). FDA records list one 510(k) clearance for Nucleix , Ltd. As of , FDA records show no recalls naming K203245.

Clearance record

Decision date
Received
(912 days to decision)
Product code
MMW System, Test, Tumor Marker, Monitoring, Bladder
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Nucleix , Ltd. 3 Pekeris St., Rehovot, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMW

Trailing 12 months

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

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