510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972676Substantially Equivalent

Urine Screening Device

Combact Diagnostic Systems, Ltd., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972676 is the FDA 510(k) clearance record for URINE SCREENING DEVICE, a class I device, cleared for Combact Diagnostic Systems , Ltd. on under FDA product code JXA (Kit, Screening, Urine). FDA records list one 510(k) clearance for Combact Diagnostic Systems , Ltd. As of , FDA records show no recalls naming K972676.

Clearance record

Decision date
Received
(222 days to decision)
Product code
JXA Kit, Screening, Urine
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Combact Diagnostic Systems , Ltd. 16809 Briardale Rd., Rockville MD
510(k) summary
Summary
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