510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864177Substantially Equivalent

N-D Urine Tube System (N-D Tube/cap/pipette)

Cls Co., Anaheim Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864177 is the FDA 510(k) clearance record for N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE), a class I device, cleared for Cls Co. on under FDA product code JXA (Kit, Screening, Urine). FDA records list one 510(k) clearance for Cls Co. As of , FDA records show no recalls naming K864177.

Clearance record

Decision date
Received
(123 days to decision)
Product code
JXA Kit, Screening, Urine
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Cls Co. 6190 Canyon Ct., Anaheim Hills CA
Third party review
No

Clearances, product code JXA

Trailing 12 months

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

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