!NSURE FECAL OCCULT BLOOD TEST

Reagent, Occult Blood

ENTERIX INC.

The following data is part of a premarket notification filed by Enterix Inc. with the FDA for !nsure Fecal Occult Blood Test.

Pre-market Notification Details

Device IDK002457
510k NumberK002457
Device Name:!NSURE FECAL OCCULT BLOOD TEST
ClassificationReagent, Occult Blood
Applicant ENTERIX INC. 348 US ROUTE ONE Falmouth,,  ME  04105
ContactRobert C Bruce
CorrespondentRobert C Bruce
ENTERIX INC. 348 US ROUTE ONE Falmouth,,  ME  04105
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-10
Decision Date2001-01-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850093003187 K002457 000
00850093003095 K002457 000
10850093003085 K002457 000
00850093003071 K002457 000
00850093003064 K002457 000
00850093003040 K002457 000
00850093003019 K002457 000

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