Panels › Clinical Chemistry › Product code LCX · Class 2
Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation 862.1155
0510(k)s in 12 months (226 all time)
2recalls in 12 months (25 all time)
16recalls that name a 510(k)
Top companies in LCX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2012 | K112449 | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST Tianjin New Bay Bioresearch Co., Ltd. | LCX |
| Oct 4, 2011 | K103487 | FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST Taidoc Technology Corporation, TW | LCX |
| Aug 3, 2011 | K102760 | ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 Atlas Medical, JO | LCX |
| Jul 28, 2011 | K103574 | PREGNANCY ONE STEP RAPID TEST Lehnus & Associates Consulting | LCX |
| Jun 20, 2011 | K110889 | IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) Ind Diagnostics, Inc., CA | LCX |
| May 12, 2011 | K110433 | CLEARBLUE EASY PREGNANCY TEST SPD Development Company Limited, GB | LCX |
| Jun 16, 2009 | K081150 | RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST Turklab Medical Devices, Inc., TR | LCX |
| Jun 8, 2009 | K083716 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) Church & Dwight Co., Inc. | LCX |
| Dec 18, 2007 | K071930 | ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C Blue Cross Bio-Medical Co., Ltd., CN | LCX |
| Jul 23, 2007 | K062703 | ONE STEP HCG PREGNANCY TEST Ai DE Diagnostic Co., Ltd. | LCX |
| May 7, 2007 | K062096 | KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST Koreamedico Co. , Ltd., KR | LCX |
| May 4, 2007 | K070054 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST Church & Dwight Co., Inc. | LCX |
| Jul 18, 2006 | K053236 | DAVID PREGNANCY TEST (MIDSTREAM) Runbio Biotech Co.,Ltd | LCX |
| Jul 3, 2006 | K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Jun 19, 2006 | K060825 | MULTI-USE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc. | LCX |
| May 25, 2006 | K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST Unipath , Ltd., GB | LCX |
| May 25, 2006 | K053452 | PURE-AID PREGNANCY TEST Bio Focus Co., Lt. | LCX |
| Mar 1, 2006 | K053138 | MYSET PREGNANCY TEST Ani Biotech OY | LCX |
| Feb 17, 2006 | K060019 | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) Artron Laboratories, Inc., CA | LCX |
| Nov 23, 2005 | K051963 | BE-CERTAIN PREGNANCY TEST Natureplex, LLC | LCX |
| May 23, 2005 | K050305 | 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 Bioscreen Medical, Inc. | LCX |
| May 20, 2005 | K050546 | ACON +/- MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. | LCX |
| May 12, 2005 | K050930 | E.P.T. CERTAINTY PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Apr 25, 2005 | K043231 | PROOF POSITIVE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc. | LCX |
| Apr 8, 2005 | K043443 | ONE STEP HCG URINE PREGNANCY TEST Guangzhou Wondfo Biotech Co., Ltd. | LCX |
| Oct 19, 2004 | K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST Armkel, LLC | LCX |
| Sep 10, 2004 | K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT Unipath , Ltd., GB | LCX |
| Sep 9, 2004 | K042151 | ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. | LCX |
| Aug 9, 2004 | K041748 | AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) Azog, Inc. | LCX |
| Jun 8, 2004 | K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST Unipath , Ltd., GB | LCX |
| May 20, 2004 | K041273 | ONE-STEP PREGNANCY TEST W.H.P.M., Inc. | LCX |
| Mar 8, 2004 | K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Mar 8, 2004 | K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Jan 16, 2004 | K033658 | E.P.T. PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Nov 21, 2003 | K033041 | ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP ACON Laboratories, Inc. | LCX |
| Nov 21, 2003 | K032992 | UNIMARK HOME PREGNANCY TEST DEVICE Biotech Atlantic, Inc. | LCX |
| Nov 12, 2003 | K031798 | GOOD MORNING TEST Standard Diagnostics, Inc. | LCX |
| Oct 20, 2003 | K032939 | EPT CERTAINTY PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Oct 14, 2003 | K032661 | ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) ACON Laboratories, Inc. | LCX |
| Sep 22, 2003 | K032510 | ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST ACON Laboratories, Inc. | LCX |
| Sep 5, 2003 | K032159 | CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY Access Bio Incorporate | LCX |
| Jun 17, 2003 | K031271 | ONE-STEP PREGNANCY TEST Amerisource Pharmacal, Inc. | LCX |
| May 2, 2003 | K030659 | CLEARBLUE EASY DIGITAL PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Apr 17, 2003 | K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST Cenogenics Corp. | LCX |
| Apr 9, 2003 | K023037 | MID STREAM PREGNANCY TEST Advanced Diagnostics, Inc. | LCX |
| Feb 25, 2003 | K030258 | FIRST RESPONSE PREGNANCY TEST Armkel, LLC | LCX |
| Jan 3, 2003 | K023638 | CASSETTE/URINE HCG Ind Diagnostic, Inc., CA | LCX |
| Dec 16, 2002 | K023027 | PREG-Q EARLY PREGNANCY TEST Yd Diagnostics | LCX |
| Nov 27, 2002 | K023699 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Nov 18, 2002 | K023126 | AMEDITECH IMMUTEST HCG PREGANCY TEST Ameditech, Inc. | LCX |
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