FDA.reportPublic FDA data

NYPRO CAROLINA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10540453001451340NYPRO CAROLINA1N2020-04-251018 Corporate Park Drive Mebane NC US 27302

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1615281445953246K984067STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKJHX1999-01-13
1615281403973471K963498FERR FLEX REAGENT CARTRIDGEJMG1997-01-24
1615282060752184K915106DIMENSION AR CLINICAL CHEMISTRY SYSTEMJJE1992-01-28
1615281849837215K860021DIMENSION(TM) CLINICAL CHEMISTRY SYSTEMJJE1986-02-11
1615281851371231K051087DIMENSION VISTA INTEGRATED SYSTEMJJE2005-07-11
1615281601536588BK970042
1615281507403373
1615281538986748
1615281871632345

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJE32005-07-11
JHX11999-01-13
JMG11997-01-24