IRISPEC,CA/CB/CC— 510(k) K072640

Substantially Equivalent

Iris Diagnostics

FDA 510(k) clearance K072640 for IRISPEC,CA/CB/CC, Substantially Equivalent on 2007-12-21. Applicant: Iris Diagnostics. Device class: 1.

Clearance details

Applicant: Iris Diagnostics
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2007-09-18
Decision date: 2007-12-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJW

K170091 — UA-Cellular Complete2017-02-09
K142262 — AUTION CHECK PLUS2015-04-10
K131444 — UA-CELLULAR COMPLETE2014-01-29
K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 22011-09-30
K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL2011-02-02

More clearances from Iris Diagnostics

K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE2010-08-31

Recalls naming K072640

K-number listed on FDA's recall record

Z-0093-2025 — Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.Class III·Ongoing·Beckman Coulter, Inc.·20240716
Z-0777-2023 — BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.Class II·Ongoing·Beckman Coulter, Inc.·20221118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072640.

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