510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082811Substantially Equivalent

Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers

URIT Medical Electronic Co., Ltd., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082811 is the FDA 510(k) clearance record for URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS, a class II device, cleared for Urit Medical Electronic Co., Ltd. on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list 2 510(k) clearances for Urit Medical Electronic Co., Ltd., from to . As of , FDA records show no recalls naming K082811.

Clearance record

Decision date
Received
(352 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Urit Medical Electronic Co., Ltd. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIO

Trailing 12 months

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

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