FDA.reportPublic FDA data

PREGMATE LLC

Matched from indexed company URL: Pregmate LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136795023013679502PREGMATE LLC1Y2026-01-013804 N 29th Ave Hollywood FL US 33020

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2089751832562101K981207CLEARPLAN EASY FERTILITY MONITORNGE1998-10-28
2089751316459898K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test MidstreamLCX2022-04-05
2089751875819734K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamLCX2020-08-13
2089751100547762K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test MidstreamLCX2019-09-05
2089751779796165K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test MarijuanaDIO2016-03-18
2089751076935617K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJG2016-04-26
2089751719738576K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette MarijuanaLDJ2015-11-02
2089751588432016K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - MethamphetamineDNK2015-07-16
2089751188424633K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test MidstreamLCX2015-08-07
2089751764400945K132085ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAMLCX2013-11-12
2089751351552659K123050EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)LCX2013-02-05
2089751419865669K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTERLCX2013-03-14
2089751204493816K063295ACON UTI URINARY TRACT INFECTION TEST STRIPSLJX2007-10-12
2089751321301976K043443ONE STEP HCG URINE PREGNANCY TESTLCX2005-04-08
2089751487925753K012252QUIK-CHECK OVULATION PREDICTORCEP2001-08-24
2089751545942692K003987URS-1K (KETONE TESST)JIN2001-04-26
2089751007907798
2089751037609316
2089751123077409
2089751123189652
2089751275206921
2089751515386650
2089751530080631
2089751724654298
2089751726362912
2089751854017960
2089751881354044
2089751907247154

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCX82022-04-05
DJG12016-04-26
DIO12016-03-18
LDJ12015-11-02
DNK12015-07-16
LJX12007-10-12
CEP12001-08-24
JIN12001-04-26
NGE11998-10-28

GUDID#