ICHEM 100 URINE CHEMISTRY ANALYZER— 510(k) K060280

Name: FDA 510(k) clearance K060280
Creator: U.S. Food and Drug Administration
Published: 2006-06-13

Substantially Equivalent

Iris International, Inc.

FDA 510(k) clearance K060280 for ICHEM 100 URINE CHEMISTRY ANALYZER, Substantially Equivalent on 2006-06-13. Applicant: Iris International, Inc.. Device class: 2.

Clearance details

Applicant: Iris International, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2006-02-02
Decision date: 2006-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060280

K-number listed on FDA's recall record

Z-0649-2016 — iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.Class II·Terminated·Beckman Coulter Inc.·20141208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060280.

Data sourced from openFDA. This site is unofficial and independent of the FDA.