510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033851Substantially Equivalent

Diascreen Reagent Strips for Urinalysis, Models D122oo (2Gk), D12100 (1K), D11100 (1G)

Arkray Factory USA, Inc., Edina MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033851 is the FDA 510(k) clearance record for DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G), a class II device, cleared for Hypoguard USA, Inc. on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 19 510(k) clearances for ARKRAY FACTORY USA, INC., from to . As of , FDA records show no recalls naming K033851.

Clearance record

Decision date
Received
(82 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hypoguard USA, Inc. 5182 W. 76th St., Edina MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

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