510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242209Substantially Equivalent

UASure II Blood Uric Acid Monitoring System

Apex Biotechnology Corp., Hsinchu, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242209 is the FDA 510(k) clearance record for UASure II Blood Uric Acid Monitoring System, a class I device, cleared for Apex BioTechnology Corp. on under FDA product code PTC (Uric Acid Test System For At Home Prescription Use). FDA's definition for product code PTC reads: "For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only". FDA records list 35 510(k) clearances for Apex BioTechnology Corp., from to . As of , FDA records show no recalls naming K242209.

Clearance record

Decision date
Received
(249 days to decision)
Product code
PTC Uric Acid Test System For At Home Prescription Use
Regulation
21 CFR 862.1775
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Apex BioTechnology Corp. #7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTC

Trailing 12 months

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

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