510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954514Substantially Equivalent

Ua Perfect Automated Analysis Assay for Urobillinogen in Urine

SCITECK Diagnostics, Arden NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954514 is the FDA 510(k) clearance record for UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE, a class I device, cleared for Sciteck Diagnostics, Inc. on under FDA product code KQO (Automated Urinalysis System). FDA records list one 510(k) clearance for Sciteck Diagnostics, Inc. As of , FDA records show no recalls naming K954514.

Clearance record

Decision date
Received
(267 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sciteck Diagnostics, Inc. P.O. Box 562, Arden NC
510(k) summary
Statement
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