QUANTIMETRIX NICOSURE COTININE URINE CONTROL— 510(k) K062942

Name: FDA 510(k) clearance K062942
Creator: U.S. Food and Drug Administration
Published: 2006-10-30

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K062942 for QUANTIMETRIX NICOSURE COTININE URINE CONTROL, Substantially Equivalent on 2006-10-30. Applicant: Quantimetrix Corp.. Device class: 1.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 2006-09-28
Decision date: 2006-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redondo Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAS

view all

K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS2009-11-17
K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL2008-01-30
K051074 — MAS IMMUNOSUPPRESSANT CONTROLS2005-06-06
K040411 — DRI OXYCODONE ASSAY2004-05-27
K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT2003-10-17

More clearances from Quantimetrix Corp.

view all

K142262 — AUTION CHECK PLUS2015-04-10
K113177 — COMPLETE D 25-OH VITAMIN D CONTROL2012-05-10
K103744 — DROPPER A1C DIABETES CONTROL2011-05-12
K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER2006-10-03
K060417 — MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL2006-03-21

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