FDA 510(k) Applications for Medical Device Product Code "LCX"
(Kit, Test, Pregnancy, Hcg, Over The Counter)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981892 | ABACUS DIAGNOSTICS | QUICK & SURE ONESTEP HOME PREGNANCY TEST | 08/18/1998 |
| K970082 | ABBOTT LABORATORIES | ABBOTT ADVISOR ONE-STEP PREGNANCY TEST | 01/24/1997 |
| K990373 | ABBOTT LABORATORIES | FACT PLUS ONE STEP PREGNANCY TEST | 02/22/1999 |
| K032159 | ACCESS BIO INCORPORATE | CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY | 09/05/2003 |
| K193318 | Acon Laboratories Inc. | Distinct« Early Detection Pregnancy Test | 08/20/2020 |
| K050546 | ACON LABORATORIES, INC. | ACON +/- MIDSTREAM PREGNANCY TEST | 05/20/2005 |
| K983090 | ACON LABORATORIES, INC. | ACON MIDSTREAM PREGNANCY TEST | 11/18/1998 |
| K993483 | ACON LABORATORIES, INC. | ACON ONE STEP HOME PREGNANCY TEST STRIP | 01/20/2000 |
| K032661 | ACON LABORATORIES, INC. | ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) | 10/14/2003 |
| K033041 | ACON LABORATORIES, INC. | ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP | 11/21/2003 |
| K032510 | ACON LABORATORIES, INC. | ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST | 09/22/2003 |
| K042151 | ACON LABORATORIES, INC. | ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST | 09/09/2004 |
| K012215 | ACON LABORATORIES, INC. | QUIK-CHECK HOME PREGNANCY TEST | 08/07/2001 |
| K172512 | ACRO Biotech, Inc. | ACRO HCG Pregnancy Rapid Test | 02/02/2018 |
| K180771 | ACRO Biotech, Inc. | Acro HCG Pregnancy Rapid Test | 05/18/2018 |
| K023037 | ADVANCED DIAGNOSTICS, INC. | MID STREAM PREGNANCY TEST | 04/09/2003 |
| K062703 | AI DE DIAGNOSTIC CO., LTD. | ONE STEP HCG PREGNANCY TEST | 07/23/2007 |
| K984075 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | 02/16/1999 |
| K023126 | AMEDITECH, INC. | AMEDITECH IMMUTEST HCG PREGANCY TEST | 11/18/2002 |
| K031271 | AMERISOURCE PHARMACAL, INC. | ONE-STEP PREGNANCY TEST | 06/17/2003 |
| K953606 | AMERITEK, INC. | BEST PREGNANCY TEST | 03/22/1996 |
| K053138 | ANI BIOTECH OY | MYSET PREGNANCY TEST | 03/01/2006 |
| K040866 | ARMKEL LLC | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | 10/19/2004 |
| K973352 | ARMKEL, LLC. | BRAND NAME *1-STEP PREGNANCY | 10/27/1997 |
| K962183 | ARMKEL, LLC. | BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES | 07/10/1996 |
| K992232 | ARMKEL, LLC. | FIRST RESPONSE 1-STEP PREGNANCY | 12/21/1999 |
| K030258 | ARMKEL, LLC. | FIRST RESPONSE PREGNANCY TEST | 02/25/2003 |
| K961712 | ARMKEL, LLC. | TBD AT-HOME PREGNANCY TEST | 05/31/1996 |
| K060019 | ARTRON LABORATORIES, INC. | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) | 02/17/2006 |
| K962888 | ATHENA MEDICAL CORP. | AFFIRM ONE-STEP HOME PREGNANCY TEST | 09/23/1996 |
| K203246 | Atlas Link Technology Co., Ltd. | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) | 08/04/2021 |
| K102760 | ATLAS MEDICAL | ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 | 08/03/2011 |
| K041748 | AZOG, INC. | AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) | 08/09/2004 |
| K053452 | BIO FOCUS CO., LT. | PURE-AID PREGNANCY TEST | 05/25/2006 |
| K970008 | BIONIKE, INC. | ADVANCED QUALITY PREGNANCY TEST | 02/18/1997 |
| K050305 | BIOSCREEN MEDICAL INC. | ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 | 05/23/2005 |
| K032992 | BIOTECH ATLANTIC, INC. | UNIMARK HOME PREGNANCY TEST DEVICE | 11/21/2003 |
| K960174 | BIOTECH ATLANTIC, INC. | UNIMARK MIDSTREAM PREGNANCY TEST STICK | 04/01/1996 |
| K071930 | BLUE CROSS BIO-MEDICAL CO., LTD. | ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C | 12/18/2007 |
| K013907 | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. | INVERNESS MEDICAL EARLY PREGNANCY TEST | 12/18/2001 |
| K955903 | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. | SELFCARE EARLY PREGNANCY TEST | 03/06/1996 |
| K030533 | CENOGENICS CORP. | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | 04/17/2003 |
| K011551 | Chembio Diagnostic Systems, Inc. | SURE CHECK PREGNANCY TEST | 08/14/2001 |
| K961965 | Chembio Diagnostic Systems, Inc. | SURE CHECK PREGNANCY TEST | 06/24/1996 |
| K131931 | CHEMTRON BIOTECH, INC. | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST | 07/26/2013 |
| K123436 | CHURCH & DWIGHT CO., INC. | FIRST RESPONSE EARLY RESULT PREGNANCY TEST | 08/26/2013 |
| K083716 | CHURCH & DWIGHT CO., INC. | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) | 06/08/2009 |
| K070054 | CHURCH & DWIGHT CO., INC. | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | 05/04/2007 |
| K123567 | CHURCH & DWIGHT CO., INC. | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | 09/10/2013 |
| K132085 | CO-INNOVATION BIOTECH CO., LTD. | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | 11/12/2013 |
| K213808 | Co-Innovation Biotech Co.,Ltd. | Co-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 Midstream | 04/05/2022 |
| K150063 | Coretests, Inc. | One Step hCG Pregnancy Test | 10/02/2015 |
| K964108 | DIRECT ACCESS DIAGNOSTICS | FACT PLUS PREGNANCY TEST | 11/18/1996 |
| K962521 | DIRECT ACCESS DIAGNOSTICS | FACTPLUS ONE STEP PREGNANCY TEST | 07/29/1996 |
| K971286 | EXCEL SCIENTIFIC, INC. | EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST | 05/08/1997 |
| K962580 | EXCEL SCIENTIFIC, INC. | EZ SURE ONESTEP EARLY PREGNANCY TEST | 08/29/1996 |
| K970425 | EXCEL SCIENTIFIC, INC. | EZ SURE URINE DIPSTICK PREGNANCY HOME TEST | 03/06/1997 |
| K991369 | GERMAINE LABORATORIES, INC. | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY | 05/10/1999 |
| K222305 | Guangzhou Decheng Biotechnology Co. Ltd. | MissLanÖ Digital Pregnancy Rapid Test | 11/30/2022 |
| K230038 | Guangzhou Decheng Biotechnology Co., Ltd. | MissLan« Pregnancy Rapid Test (Strip), MissLan« Pregnancy Rapid Test (Midstream) | 02/28/2023 |
| K043443 | Guangzhou Wondfo Biotech Co., Ltd. | ONE STEP HCG URINE PREGNANCY TEST | 04/08/2005 |
| K173229 | Guangzhou Wondfo Biotech Co., Ltd. | Preview Digital Pregnancy Test | 03/12/2018 |
| K150022 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | 08/07/2015 |
| K193132 | Hangzhou Clongene Biotech Co.,Ltd. | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream | 12/11/2019 |
| K212447 | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | 02/18/2022 |
| K123703 | HEALGEN SCIENTIFIC, LLC | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) | 04/10/2013 |
| K212418 | Healstone Biotech Inc. | hCG One Step Pregnancy Test | 06/30/2022 |
| K023638 | IND DIAGNOSTIC INC. | CASSETTE/URINE HCG | 01/03/2003 |
| K110889 | IND DIAGNOSTICS INC. | IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) | 06/20/2011 |
| K192843 | Innovita (Tangshan) Biological Technology Co., Ltd | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | 11/22/2019 |
| K974059 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. | ONE STEP MIDSTREAM HCG PREGNANCY TEST | 04/09/1998 |
| K062096 | KOREAMEDICO CO. LTD. | KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST | 05/07/2007 |
| K103574 | Lehnus & Associates Consulting | PREGNANCY ONE STEP RAPID TEST | 07/28/2011 |
| K171136 | LIA Diagnostics | LIA Pregnancy Test | 11/20/2017 |
| K060825 | MIZUHO USA, INC. | MULTI-USE ELECTRONIC PREGNANCY TEST | 06/19/2006 |
| K964002 | MIZUHO USA, INC. | NATURALE HCG PREGNANCY TES | 11/07/1996 |
| K043231 | MIZUHO USA, INC. | PROOF POSITIVE ELECTRONIC PREGNANCY TEST | 04/25/2005 |
| K123050 | NANTONG BIOTECHNOLOGY CO., LTD. | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | 02/05/2013 |
| K051963 | NATUREPLEX, LLC | BE-CERTAIN PREGNANCY TEST | 11/23/2005 |
| K993141 | PHAMATECH | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 | 11/08/1999 |
| K973570 | PHAMATECH | QUICK CARD HCG ONE STEP PREGNANCY TEST | 10/31/1997 |
| K972682 | PHAMATECH | QUICKSTICK ONE STEP HCG PREGNANCY TEST | 08/01/1997 |
| K962219 | PHAMATECH | QUICKSTICK ONE STEP PREGNANCY TEST(9010) | 07/23/1996 |
| K980532 | PHAMATECH | QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 | 03/11/1998 |
| K122907 | POLYMED THERAPEUTICS, INC | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | 03/14/2013 |
| K192123 | Qingdao Hightop Biotech Co., Ltd. | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | 09/05/2019 |
| K974821 | QUIDEL CORP. | BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST | 01/26/1998 |
| K981722 | QUIDEL CORP. | QUIDEL HOME PREGNANCY TEST | 06/03/1998 |
| K053236 | RUNBIO BIOTECH CO., LTD. | DAVID PREGNANCY TEST (MIDSTREAM) | 07/18/2006 |
| K172627 | Runbio BioTech Co.,Ltd | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | 03/28/2018 |
| K181551 | Runbio BioTech Co.,Ltd | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | 02/22/2019 |
| K974154 | SA SCIENTIFIC, INC. | CHOICE ACCU-TEST PREGNANCY TEST KIT | 12/19/1997 |
| K991193 | SA SCIENTIFIC, INC. | SAS HCG-CHECK | 05/04/1999 |
| K974021 | SA SCIENTIFIC, INC. | SIGNAL PREGNANCY TEST KIT | 12/19/1997 |
| K200133 | Safecare Biotech (Hangzhou) Co., Ltd. | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | 08/13/2020 |
| K962721 | SALIVA DIAGNOSTIC SYSTEMS | EVIDENCE PREGNANCY TEST | 10/01/1996 |
| K002049 | SELFCARE, INC. | INVERNESS MEDICAL EARLY PREGNANCY TEST | 07/27/2000 |
| K960436 | SELFCARE, INC. | SELFCARE EARLY PREGNANCY TEST | 03/19/1996 |
| K110433 | SPD DEVELOPMENT COMPANY LIMITED | CLEARBLUE EASY PREGNANCY TEST | 05/12/2011 |
| K213379 | SPD Swiss Precision Diagnostics GmbH | Clearblue « Early Pregnancy Test | 09/21/2022 |
| K200913 | SPD Swiss Precision Diagnostics GmbH | Clearblue« Early Digital Pregnancy Test | 08/13/2021 |
| K210341 | SPD Swiss Precision Diagnostics GmbH | One Step Pregnancy Test | 03/10/2022 |
| K031798 | STANDARD DIAGNOSTICS, INC. | GOOD MORNING TEST | 11/12/2003 |
| K142754 | Sugentech, Inc. | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test | 04/07/2016 |
| K963341 | SYNTRON BIORESEARCH, INC. | MIDSTREAM ONESTEP PREGNANCY HOME TEST | 12/02/1996 |
| K960117 | SYNTRON BIORESEARCH, INC. | PLATFORM ONESTEP PREGNANCY HOME TEST | 03/19/1996 |
| K103487 | TaiDoc Technology Corporation | FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST | 10/04/2011 |
| K973208 | TEXAS IMMUNOLOGY, INC. | FIRST SIGN | 10/20/1997 |
| K112449 | Tianjin New Bay Bioresearch Co., Ltd. | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST | 09/24/2012 |
| K182328 | True Diagnostics, Inc. | VeriClear Digital Early Result Pregnancy Test | 05/15/2019 |
| K081150 | TURKLAB MEDICAL DEVICES INC | RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST | 06/16/2009 |
| K131236 | UCP BIOSCIENCES, INC. | UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP | 11/07/2013 |
| K960316 | UNIPATH LTD. | CLEARBLUE EASY | 04/29/1996 |
| K030659 | UNIPATH LTD. | CLEARBLUE EASY DIGITAL PREGNANCY TEST | 05/02/2003 |
| K060128 | UNIPATH LTD. | CLEARBLUE EASY DIGITAL PREGNANCY TEST | 05/25/2006 |
| K040341 | UNIPATH LTD. | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | 03/08/2004 |
| K013372 | UNIPATH LTD. | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | 11/09/2001 |
| K023699 | UNIPATH LTD. | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | 11/27/2002 |
| K041404 | UNIPATH LTD. | CLEARBLUE EASY EASY READ PREGNANCY TEST | 06/08/2004 |
| K990262 | UNIPATH LTD. | CLEARPLAN EASY HOME PREGNANCY TEST | 04/07/1999 |
| K993333 | UNIPATH LTD. | CLEARPLAN EASY II HOME PREGNANCY TEST | 12/16/1999 |
| K061769 | UNIPATH LTD. | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | 07/03/2006 |
| K050930 | UNIPATH LTD. | E.P.T. CERTAINTY PREGNANCY TEST | 05/12/2005 |
| K033658 | UNIPATH LTD. | E.P.T. PREGNANCY TEST | 01/16/2004 |
| K032939 | UNIPATH LTD. | EPT CERTAINTY PREGNANCY TEST | 10/20/2003 |
| K042280 | UNIPATH LTD. | FACT PLUS ONE-STEP PREGNANCY TEST KIT | 09/10/2004 |
| K040329 | UNIPATH LTD. | MODIFICATION TO E.P.T. PREGNANCY TEST | 03/08/2004 |
| K960733 | VANGUARD BIOMEDICAL CORP. | MINISTICK PREGNANCY TEST | 05/01/1996 |
| K041273 | W.H.P.M., INC. | ONE-STEP PREGNANCY TEST | 05/20/2004 |
| K183097 | Weihai Kangzhou Biotechnology Engineering Co., Ltd | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream | 01/10/2019 |
| K190705 | Wholepower Biotech Co., Ltd. | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream | 04/15/2019 |
| K990576 | WYNTEK DIAGNOSTICS, INC. | OSOM CARD PREGNANCY TEST, MODEL 103 | 03/09/1999 |
| K965184 | WYNTEK DIAGNOSTICS, INC. | PERFECTA PREGNANCY TEST | 02/04/1997 |
| K023027 | YD DIAGNOSTICS | PREG-Q EARLY PREGNANCY TEST | 12/16/2002 |
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