FDA.reportPublic FDA data

ENTERIX INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12267693003224146ENTERIX INC.1N2026-01-01236 Fernwood Ave EDISON NJ US 08837
12267693003224146ENTERIX INC.1N2020-04-25236 Fernwood Ave EDISON NJ US 08837

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850093003231InSure® ONE™ - InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run Buffer (9mL)18005313681xx@xx.xx
00850093003279InSure® ONE™ - InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit18005313681xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
580041812606600K170548InSure ONEKHE2017-10-05
3245532018892769K170548InSure ONEKHE2017-10-05
580041293487923K101831ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800OSL2010-10-01
3245531605201509K101831ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800OSL2010-10-01
580041175906011K002457!NSURE FECAL OCCULT BLOOD TESTKHE2001-01-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KHE32017-10-05
OSL22010-10-01

PMN#

GUDID#