FDA.reportPublic FDA data

510(k) K170548

Device
InSure ONE
Applicant
Enterix Inc.
510(k) number
K170548
Product code
KHE  
Decision
Substantially Equivalent (SESE)
Decision date
2017-10-05
Date received
2017-02-24
Regulation
864.6550
Classification name
Reagent, Occult Blood
Medical specialty
Hematology
Review panel
Hematology
Clearance type
Traditional
Third party reviewed
No

Other 510(k) Records For Product Code KHE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.2018-02-15
K171484hema-screen SPECIFIC GoldImmunostics Inc.,2017-06-14
K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.2017-05-14
K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,2017-01-17
K143325OC-Light S FITEiken Chemical Co., Ltd.2015-08-20
K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC2012-12-28
K113506IND ONE STEP OCCULT BLOOD (FOB) TESTInd Diagnostics, Inc.2012-12-19
K110309FOB ONE STEP RAPID TESTOrient Gene Biotech2011-09-14
K102664HEMA SCREEN ERImmunostics Inc.,2011-01-28
K100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10Ind Diagnostic, Inc.2010-07-19
K100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TESTPrinceton BioMeditech Corp.2010-07-01
K080812HEMOCCULT ICTBeckman Coulter, Inc.2008-06-25
K071242DBEST ONE STEP OCCULT BLOOD TEST KITSAmeritek USA, Inc.2008-03-06
K073431FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME TTianjin New Bay Bioresearch Co., Ltd.2008-01-14
K070660INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TESTAlfa Scientific Designs, Inc.2007-06-21

Legacy Summary#

summary

FDA Review#

Decision Summary