FDA.reportPublic FDA data

AMERITEKUSA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30256721000126037AMERITEKUSA, INC.1N2026-01-01125 130th St SE Ste 200 EVERETT WA US 98208

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
125641235151735K990873DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEJMT1999-09-01
125642030571169K990681DBSET MULTIDRUG SCREEN TEST KITDKZ1999-07-15
125641752760847K984269DBEST OCCULT BLOOD TEST KITKHE1999-05-11
125641226982023K983191DBEST COCAINE TEST KITDIO1998-11-18
125641129688993K983190DBEST OPIATES TEST KITDJG1998-11-18
125641933825471K983189DBEST METHAMPHETAMINES TEST KITLAF1998-11-18
125641217819784K983188DBEST TETRAHYDROCANNABINOL TEST KITLDJ1998-11-18
125641188390168K981504DBEST AMPHETAMINES TEST KITDKZ1998-08-06
125641624909931K974508DBEST ONE-STEP OVULATION TESTCEP1998-02-02
125641286502055K973957DBEST ONE-STEP HCG SERUM/URINE TESTJHI1997-12-17
125641557648298K973957DBEST ONE-STEP HCG SERUM/URINE TESTJHI1997-12-17
125641750955249K973142DBEST REAGENT STRIP FOR URINALYSISJIL1997-10-20
125641608251168K953606BEST PREGNANCY TESTLCX1996-03-22
125641819430899K071242DBEST ONE STEP OCCULT BLOOD TEST KITSKHE2008-03-06
125641641146430K061257DBEST HCG PANEL TEST KITJHI2007-05-04
125642056083061K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITJTO2005-09-01
125641501760727K001215DBEST HCG 2 IU/ML TEST KITJHI2000-06-22
125641536419354
125641657434420
125641682838532
125641707196404
125641938234395

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JHI52007-05-04
KHE22008-03-06
DKZ21999-07-15
JTO12005-09-01
JMT11999-09-01
LAF11998-11-18
LDJ11998-11-18
DIO11998-11-18
DJG11998-11-18
CEP11998-02-02
JIL11997-10-20
LCX11996-03-22