Medical Device Manufacturer · US , Mchenry , IL

Quantimetrix Corp.

38 submissions · 38 cleared · Since 1983
38
Total
38
Cleared
0
Denied

Quantimetrix Corp. — FDA 510(k) Submissions

Quantimetrix Corp. has submitted 38 FDA 510(k) premarket notifications since 1983, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Drug Mixture Control Materials, Single (specified) Analyte Controls (assayed And Unassayed), Enzyme Controls (assayed And Unassayed), Electrolyte Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
AUTION CHECK PLUS
K142262 · JJW Urinalysis Controls... · Chemistry
Apr 2015 239d
COMPLETE D 25-OH VITAMIN D CONTROL
K113177 · JJX Single (specified)... · Chemistry
May 2012 195d
DROPPER A1C DIABETES CONTROL
K103744 · JJX Single (specified)... · Chemistry
May 2011 140d
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
K062942 · LAS Drug Specific Control... · Toxicology
Oct 2006 32d
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · JJT Enzyme Controls (assayed... · Chemistry
Oct 2006 19d
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K060417 · DIF Drug Mixture Control... · Toxicology
Mar 2006 32d
GLYCOHEMOSURE HBA1C CONTROL
K032791 · GGM Control, Hemoglobin · Chemistry
Oct 2003 52d
PRECISET DAT AMPHETAMINE
K030826 · DIJ Lead, Delta Amino... · Toxicology
Apr 2003 20d
PRECISET DAT PLUS
K021393 · DKB Calibrators, Drug Mixture · Toxicology
Jun 2002 42d
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · JHO Electrophoretic... · Chemistry
Mar 2002 122d
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · JHO Electrophoretic... · Chemistry
Jul 2001 170d
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · JPK Mixture, Hematology... · Hematology
Mar 2001 23d
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · JJT Enzyme Controls (assayed... · Chemistry
Nov 1999 20d
IMMUSURE
K973894 · JJY Multi-analyte Controls,... · Chemistry
Oct 1997 15d
SPINALSCOPICS
K970862 · JJY Multi-analyte Controls,... · Chemistry
Apr 1997 32d
PROSTAT CONTROL
K943394 · JJY Multi-analyte Controls,... · Immunology
May 1995 313d
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · JJR Electrolyte Controls... · Chemistry
Oct 1994 53d
ASSURE URINE HCG CONTROL
K941130 · JJX Single (specified)... · Chemistry
Jun 1994 86d
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623 · JIX Calibrator, Multi-analyte... · Chemistry
Dec 1993 191d
QUANTIMETRIX C-CLEAR(TM)
K931523 · JMA Acid, Ascorbic,... · Chemistry
Jun 1993 91d
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
K925256 · JJY Multi-analyte Controls,... · Hematology
Mar 1993 133d
QUANTIMETRIX AMMONIA CONTROLS
K913346 · JJX Single (specified)... · Chemistry
Sep 1991 61d
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · JJT Enzyme Controls (assayed... · Chemistry
Mar 1988 31d
QUANTIMETRIX DRUG FREE SERUM CONTROL
K863388 · DIF Drug Mixture Control... · Toxicology
Sep 1986 26d
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
K861420 · JJY Multi-analyte Controls,... · Chemistry
Sep 1986 154d
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