INSURE II

Reagent, Occult Blood

ENTERIX INC.

The following data is part of a premarket notification filed by Enterix Inc. with the FDA for Insure Ii.

Pre-market Notification Details

Device IDK060930
510k NumberK060930
Device Name:INSURE II
ClassificationReagent, Occult Blood
Applicant ENTERIX INC. 236 FERNWOOD AVE. Edison,  NJ  08837
ContactEdwin Diaz
CorrespondentEdwin Diaz
ENTERIX INC. 236 FERNWOOD AVE. Edison,  NJ  08837
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-05
Decision Date2006-05-04

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