FDA.reportPublic FDA data

QUANTIMETRIX CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20207152020715QUANTIMETRIX CORP.1N2026-01-012005 Manhattan Beach Blvd REDONDO BEACH CA US 90278

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
340901591494480K970862SPINALSCOPICSJJY1997-04-08
340901095704508K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGJJR1994-10-04
340901157718350K925256QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROLJJY1993-03-01
340901321565157K913346QUANTIMETRIX AMMONIA CONTROLSJJX1991-09-25
340901712211389K904603QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEMCEK1991-01-25
340902062658979K874890QUANTIMETRIX URINE DIPSTICK CONTROLJJW1988-01-21
340901319934406K860942QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUIDJJY1986-05-23
340901219128885K853932QUANTTEST TOTAL PROTEIN ASSAYCEK1985-12-19
340901810622466K831527SPINAL FLUID TOTAL PROTEIN CONTROLJJX1983-07-18
340901033273992K831526URINE TOTAL PROTEIN CONTROLJJW1983-08-12
340901988255693K152117Dropper hsCRP High Sensitivity CRP ControlJJX2016-04-21
340902072590150K142262AUTION CHECK PLUSJJW2015-04-10
340901564541851K113177COMPLETE D 25-OH VITAMIN D CONTROLJJX2012-05-10
340901205237117K103744DROPPER A1C DIABETES CONTROLJJX2011-05-12
340901544897953K013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSJHO2002-03-08
340901295232601K010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSJHO2001-07-25
340901647388968
340901121014723
340901258134395
340901284515800
340901409293972

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX52016-04-21
JJW32015-04-10
JJY31997-04-08
CEK31991-01-25
JHO22002-03-08
JJR11994-10-04