510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980047Substantially Equivalent

Uriscan S-300 Semi-Automated Urine Chemistry Analyzer

Yeongdong Pharmaceutical Corp., Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980047 is the FDA 510(k) clearance record for URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER, a class I device, cleared for Yeongdong Pharmaceutical Corp. on under FDA product code KQO (Automated Urinalysis System). FDA records list one 510(k) clearance for Yeongdong Pharmaceutical Corp. As of , FDA records show no recalls naming K980047.

Clearance record

Decision date
Received
(155 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Yeongdong Pharmaceutical Corp. 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Summary
Third party review
No

Clearances, product code KQO

Trailing 12 months

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

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