Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Quantimetrix with 39 510(k) clearances and 1 device recall. The most recent is a device recall dated Dec 21, 2017: Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper P….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 21, 2017 | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intClass III · The kits contained an incorrect lot of Dropper Plus Level 1 vials | Device recalls |
| Apr 21, 2016 | Dropper hsCRP High Sensitivity CRP ControlK152117 · JJX | 510(k) clearances |
| Apr 10, 2015 | AUTION CHECK PLUSK142262 · JJW | 510(k) clearances |
| May 10, 2012 | COMPLETE D 25-OH VITAMIN D CONTROLK113177 · JJX | 510(k) clearances |
| May 12, 2011 | DROPPER A1C DIABETES CONTROLK103744 · JJX | 510(k) clearances |
| Oct 30, 2006 | QUANTIMETRIX NICOSURE COTININE URINE CONTROLK062942 · LAS | 510(k) clearances |
| Oct 3, 2006 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK062751 · JJT | 510(k) clearances |
| Mar 21, 2006 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK060417 · DIF | 510(k) clearances |
| Oct 30, 2003 | GLYCOHEMOSURE HBA1C CONTROLK032791 · GGM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
