Medical Device Manufacturer · US , Mchenry , IL

Quantimetrix Corp. - FDA 510(k) Cleared Devices

38 submissions · 38 cleared · Since 1983

38

Total

38

Cleared

0

Denied

Quantimetrix Corp. — FDA 510(k) Products and Clearance History Chemistry ✕

27 devices

1-12 of 27

Cleared Apr 10, 2015

AUTION CHECK PLUS

Chemistry · 239d

Cleared May 10, 2012

COMPLETE D 25-OH VITAMIN D CONTROL

Chemistry · 195d

Cleared May 12, 2011

DROPPER A1C DIABETES CONTROL

Chemistry · 140d

Cleared Oct 03, 2006

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

Chemistry · 19d

Cleared Oct 30, 2003

GLYCOHEMOSURE HBA1C CONTROL

Chemistry · 52d

Cleared Mar 08, 2002

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

Chemistry · 122d

Cleared Jul 25, 2001

LIPOPRINT SYSTEM, LDL SUBFRACTIONS

Chemistry · 170d

Cleared Nov 23, 1999

CARDIASURE CARDIAC MARKERS CONTROL

Chemistry · 20d

Cleared Oct 29, 1997

Chemistry · 15d

Cleared Apr 08, 1997

Chemistry · 32d

Cleared Oct 04, 1994

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING

Chemistry · 53d

Cleared Jun 03, 1994

ASSURE URINE HCG CONTROL

Chemistry · 86d