FDA.reportPublic FDA data

TOPTOLIFE DIAGNOSTICS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30424718403042471840TOPTOLIFE DIAGNOSTICS LLC1Y2026-01-014023 Kennett Pike #50076 Wilmington DE US 19807

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3461821794350763K162333Wondfo One Step Fecal Occult Blood (FOB) TestKHE2017-05-14
3461821894822748K133343WONDFO RAPID STREP A TESTGTY2014-01-31
3461822070147338K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALJIO2012-04-17
3461821453947931K072500ONE STEP HCG URINE/SERUM TESTDHA2009-04-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KHE12017-05-14
GTY12014-01-31
JIO12012-04-17
DHA12009-04-21