Company ยท US
Quantimetrix Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2016. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 9 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 |
| DIF | Drug Mixture Control Materials | 5 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 4 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 3 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| JHO | Electrophoretic Separation, Lipoproteins | 2 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 2 |
| JPK | Mixture, Hematology Quality Control | 2 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| DIJ | Lead, Delta Amino Levulinic Acid | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| GGM | Control, Hemoglobin | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | 1 |
| LAS | Drug Specific Control Materials | 1 |
| LDP | Colorimetry, Acetaminophen | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2016 | K152117 | Dropper hsCRP High Sensitivity CRP Control Quantimetrix Corporation | JJX |
| Apr 10, 2015 | K142262 | AUTION CHECK PLUS Quantimetrix Corp. | JJW |
| May 10, 2012 | K113177 | COMPLETE D 25-OH VITAMIN D CONTROL Quantimetrix Corp. | JJX |
| May 12, 2011 | K103744 | DROPPER A1C DIABETES CONTROL Quantimetrix Corp. | JJX |
| Oct 30, 2006 | K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL Quantimetrix Corp. | LAS |
| Oct 3, 2006 | K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER Quantimetrix Corp. | JJT |
| Mar 21, 2006 | K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL Quantimetrix Corp. | DIF |
| Oct 30, 2003 | K032791 | GLYCOHEMOSURE HBA1C CONTROL Quantimetrix Corp. | GGM |
| Apr 3, 2003 | K030826 | PRECISET DAT AMPHETAMINE Quantimetrix Corp. | DIJ |
| Jun 13, 2002 | K021393 | PRECISET DAT PLUS Quantimetrix Corp. | DKB |
| Mar 8, 2002 | K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS Quantimetrix Corp. | JHO |
| Jul 25, 2001 | K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS Quantimetrix Corp. | JHO |
| Mar 23, 2001 | K010598 | SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL Quantimetrix Corp. | JPK |
| Nov 23, 1999 | K993723 | CARDIASURE CARDIAC MARKERS CONTROL Quantimetrix Corp. | JJT |
| Oct 29, 1997 | K973894 | IMMUSURE Quantimetrix Corp. | JJY |
| Apr 8, 1997 | K970862 | SPINALSCOPICS Quantimetrix Corp. | JJY |
| May 23, 1995 | K943394 | PROSTAT CONTROL Quantimetrix Corp. | JJY |
| Oct 4, 1994 | K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING Quantimetrix Corp. | JJR |
| Jun 3, 1994 | K941130 | ASSURE URINE HCG CONTROL Quantimetrix Corp. | JJX |
| Dec 9, 1993 | K932623 | QUANTIMETRIX BLOOD GLUCOSE CONTROLS Quantimetrix Corp. | JIX |
| Jun 25, 1993 | K931523 | QUANTIMETRIX C-CLEAR(TM) Quantimetrix Corp. | JMA |
| Mar 1, 1993 | K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL Quantimetrix Corp. | JJY |
| Sep 25, 1991 | K913346 | QUANTIMETRIX AMMONIA CONTROLS Quantimetrix Corp. | JJX |
| Mar 24, 1988 | K880701 | QUANTIMETRIX SERUM ENZYME CONTROL Quantimetrix Corp. | JJT |
| Sep 29, 1986 | K863388 | QUANTIMETRIX DRUG FREE SERUM CONTROL Quantimetrix Corp. | DIF |
| Sep 16, 1986 | K861420 | QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL Quantimetrix Corp. | JJY |
| May 23, 1986 | K860942 | QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID Quantimetrix Corp. | JJY |
| Dec 19, 1985 | K853932 | QUANTTEST TOTAL PROTEIN ASSAY Quantimetrix Corp. | CEK |
| Dec 10, 1985 | K853930 | QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT Quantimetrix Corp. | CEK |
| Oct 4, 1985 | K853933 | QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL Quantimetrix Corp. | DIF |
| Oct 4, 1985 | K853931 | QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL Quantimetrix Corp. | JJY |
| Oct 30, 1984 | K843818 | HUMAN SERUM ANTICONVULSANT DRUG CONTROL Quantimetrix Corp. | DIF |
| Oct 5, 1984 | K843679 | HUMAN SERUM CARDIOACTIVE DRUG CONTROL Quantimetrix Corp. | DIF |
| Apr 13, 1984 | K834505 | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID Quantimetrix Corp. | JJR |
| Oct 4, 1983 | K832045 | ACETAMINOPHER ASSAY KIT Quantimetrix Corp. | LDP |
| Aug 12, 1983 | K831526 | URINE TOTAL PROTEIN CONTROL Quantimetrix Corp. | JJW |
| Jul 18, 1983 | K831527 | SPINAL FLUID TOTAL PROTEIN CONTROL Quantimetrix Corp. | JJX |
| Jul 7, 1983 | K831336 | SALICYLATE ASSAY KIT Quantimetrix Corp. | DKJ |
| Apr 18, 1983 | K830934 | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN Quantimetrix Corp. | CJW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2017 | Quantimetrix Corporation Dropper Plus Point-of-Care Urinalysis Dipstick Control kit
The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin Terminated |
JJW | K874890 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix Synovialscopics Synovial Fluid Control.
Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial flui Terminated |
JPK | K010598 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix SpinalScopics Spinal Fluid Cell Count Control.
Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient c Terminated |
JJY | K970862 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control.
The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis r Terminated |
JJW | K874890 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix QuanTscopics Urine Microscopics Control.
QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a m Terminated |
JJY | K925256 |