510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K171083Substantially Equivalent

iChemVELOCITY Automated Urine Chemistry System

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

K171083 is the FDA 510(k) clearance record for iChemVELOCITY Automated Urine Chemistry System, a class II device, cleared for Iris Diagnostics, A Division of Iris International, Inc. on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list one 510(k) clearance for Iris Diagnostics, A Division of Iris International, Inc. As of , FDA records show no recalls naming K171083.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Iris Diagnostics, A Division of Iris International, Inc. 9172 Eton Ave., Chatsworth CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

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