510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972382Substantially Equivalent

Ub Analyzer Ua-2, Reagent Kit and Bilirubin Control

Arrows Co., Ltd., Osaka, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972382 is the FDA 510(k) clearance record for UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL, a class II device, cleared for Arrows Co., Ltd. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list one 510(k) clearance for Arrows Co., Ltd. As of , FDA records show no recalls naming K972382.

Clearance record

Decision date
Received
(445 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Arrows Co., Ltd. 2-7-50 Nishimiyahara Yodoga-Ku, Osaka, JP
510(k) summary
Summary
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260