510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060280Substantially Equivalent

Ichem 100 Urine Chemistry Analyzer

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

K060280 is the FDA 510(k) clearance record for ICHEM 100 URINE CHEMISTRY ANALYZER, a class II device, cleared for Iris International, Inc. on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 3 510(k) clearances for Iris International, Inc., from to . As of , FDA records show one recall naming K060280.

Clearance record

Decision date
Received
(131 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 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