510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101852Substantially Equivalent

Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit

Iris International Inc., A Division of Iris Iris I, Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101852 is the FDA 510(k) clearance record for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT, a class I device, cleared for Iris International Inc., A Division of Iris Iris I on under FDA product code KQO (Automated Urinalysis System). FDA records list one 510(k) clearance for Iris International Inc., A Division of Iris Iris I. As of , FDA records show 11 recalls naming K101852.

Clearance record

Decision date
Received
(265 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Iris International Inc., A Division of Iris Iris I 9172 Eton Ave., Chatsworth CA
510(k) summary
Summary PDF
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