510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030650Substantially Equivalent

Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions

Uridynamics, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030650 is the FDA 510(k) clearance record for STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS, a class I device, cleared for Uridynamics, Inc. on under FDA product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)). FDA records list one 510(k) clearance for Uridynamics, Inc. As of , FDA records show no recalls naming K030650.

Clearance record

Decision date
Received
(45 days to decision)
Product code
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1550
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Uridynamics, Inc. 6786 Hawthorne Park Dr., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEN

Trailing 12 months

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

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