FDA.reportPublic FDA data

HEMOSURE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30093884883009388488HEMOSURE, INC.1Y2020-04-255358 Irwindale Avenue Irwindale CA US 91706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1917381265742567K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.DJG2015-11-09
1917381031329026K151441First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR2015-06-29
1917381071436437K150162First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF2015-02-26
1917381697530739K142353First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestDIO2014-10-07
1917381421448046K052197FIRST SIGN DRUG OF ABUSE URINE SCREENING TESTDJR2006-06-09
1917381136004477K051841WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TESTJHI2005-08-22
1917381813210905K041273ONE-STEP PREGNANCY TESTLCX2004-05-20
1917381977517878K041202HEMOSURE ONE-STEP FECAL OCCULT BLOOD TESTKHE2004-08-12
1917381795054258K032575FIRST SIGN DRUG OF ABUSE SCREENING TESTDKZ2004-05-19
1917381450257519K012284WH ACCU TEST PREGNANCY TESTJHI2001-08-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJR22015-06-29
JHI22005-08-22
DJG12015-11-09
LAF12015-02-26
DIO12014-10-07
KHE12004-08-12
LCX12004-05-20
DKZ12004-05-19

GUDID#

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