IRI SPEC URINALYSIS CONTROL— 510(k) K832713

Name: FDA 510(k) clearance K832713
Creator: U.S. Food and Drug Administration
Published: 1983-12-22

Substantially Equivalent

Intl. Remote Imaging Systems

FDA 510(k) clearance K832713 for IRI SPEC URINALYSIS CONTROL, Substantially Equivalent on 1983-12-22. Applicant: Intl. Remote Imaging Systems. Device class: 1.

Clearance details

Applicant: Intl. Remote Imaging Systems
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1983-08-12
Decision date: 1983-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJW

view all

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 Intl. Remote Imaging Systems

view all

K022774 — IQ 200 SYSTEM2002-10-21
K000373 — 939UDX URINE PATHOLOGY SYSTEM2000-04-14
K972141 — THE YELLOW IRIS URINALYSIS WORKSTATION1997-08-25
K953116 — WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER1996-05-13
K960054 — 900UDX URINE PATHOLOGY SYSTEM1996-03-22

Recalls naming K832713

K-number listed on FDA's recall record

Z-1328-2013 — Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.Class II·Terminated·Iris Diagnostics·20120918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K832713.

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