FDA.reportPublic FDA data

VIVACHEK LABORATORIES, INC.,

Matched from indexed company URL: VIVACHEK LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30123559333012355933VIVACHEK LABORATORIES, INC.,1N2020-04-25913 N Market Street, Suite 200 Wilmington DE US 19801

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2090951168318764K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring SystemNBW2018-12-19
2090951818459840K160179VivaChek Ino Blood Glucose Monitoring SystemNBW2017-04-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW22018-12-19

PMN#