Helena Laboratories UK Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097360033009736003Helena Laboratories UK Ltd1N2027-01-01Queensway South Team Valley Trading Estate Gateshead Newcastle upon Tyne GB NE11 0SD

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1436021153170230K111369THE HELENA V8 IMMUNODISPLACEMENT KITCFF2012-06-26
1436021828476922

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CFF12012-06-26

PMN#