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 |
|---|---|---|---|
| Dec 18, 2001 | K013907 | INVERNESS MEDICAL EARLY PREGNANCY TEST Cambridge Diagnostics Ireland, Ltd., IE | LCX |
| Nov 9, 2001 | K013372 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST Unipath , Ltd. | LCX |
| Aug 14, 2001 | K011551 | SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc. | LCX |
| Aug 7, 2001 | K012215 | QUIK-CHECK HOME PREGNANCY TEST ACON Laboratories, Inc. | LCX |
| Jul 27, 2000 | K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST Selfcare, Inc. | LCX |
| Jan 20, 2000 | K993483 | ACON ONE STEP HOME PREGNANCY TEST STRIP ACON Laboratories, Inc. | LCX |
| Dec 21, 1999 | K992232 | FIRST RESPONSE 1-STEP PREGNANCY Armkel, LLC | LCX |
| Dec 16, 1999 | K993333 | CLEARPLAN EASY II HOME PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Nov 8, 1999 | K993141 | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 Phamatech | LCX |
| May 10, 1999 | K991369 | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY Germaine Laboratories, Inc. | LCX |
| May 4, 1999 | K991193 | SAS HCG-CHECK Sa Scientific, Inc. | LCX |
| Apr 7, 1999 | K990262 | CLEARPLAN EASY HOME PREGNANCY TEST Unipath , Ltd., GB | LCX |
| Mar 9, 1999 | K990576 | OSOM CARD PREGNANCY TEST, MODEL 103 Wyntek Diagnostics, Inc. | LCX |
| Feb 22, 1999 | K990373 | FACT PLUS ONE STEP PREGNANCY TEST Abbott Laboratories | LCX |
| Feb 16, 1999 | K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST Alfa Scientific Designs, Inc. | LCX |
| Nov 18, 1998 | K983090 | ACON MIDSTREAM PREGNANCY TEST ACON Laboratories, Inc. | LCX |
| Aug 18, 1998 | K981892 | QUICK & SURE ONESTEP HOME PREGNANCY TEST Abacus Diagnostics | LCX |
| Jun 3, 1998 | K981722 | QUIDEL HOME PREGNANCY TEST Quidel Corp. | LCX |
| Apr 9, 1998 | K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST International Newtech Development, Inc., CA | LCX |
| Mar 11, 1998 | K980532 | QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 Phamatech | LCX |
| Jan 26, 1998 | K974821 | BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST Quidel Corp. | LCX |
| Dec 19, 1997 | K974154 | CHOICE ACCU-TEST PREGNANCY TEST KIT Sa Scientific, Inc. | LCX |
| Dec 19, 1997 | K974021 | SIGNAL PREGNANCY TEST KIT Sa Scientific, Inc. | LCX |
| Oct 31, 1997 | K973570 | QUICK CARD HCG ONE STEP PREGNANCY TEST Phamatech | LCX |
| Oct 27, 1997 | K973352 | BRAND NAME *1-STEP PREGNANCY Armkel, LLC | LCX |
| Oct 20, 1997 | K973208 | FIRST SIGN Texas Immunology, Inc. | LCX |
| Aug 1, 1997 | K972682 | QUICKSTICK ONE STEP HCG PREGNANCY TEST Phamatech | LCX |
| May 8, 1997 | K971286 | EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST Excel Scientific, Inc. | LCX |
| Mar 6, 1997 | K970425 | EZ SURE URINE DIPSTICK PREGNANCY HOME TEST Excel Scientific, Inc. | LCX |
| Feb 18, 1997 | K970008 | ADVANCED QUALITY PREGNANCY TEST Bionike, Inc. | LCX |
| Feb 4, 1997 | K965184 | PERFECTA PREGNANCY TEST Wyntek Diagnostics, Inc. | LCX |
| Jan 24, 1997 | K970082 | ABBOTT ADVISOR ONE-STEP PREGNANCY TEST Abbott Laboratories | LCX |
| Dec 2, 1996 | K963341 | MIDSTREAM ONESTEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Nov 18, 1996 | K964108 | FACT PLUS PREGNANCY TEST Direct Access Diagnostics | LCX |
| Nov 7, 1996 | K964002 | NATURALE HCG PREGNANCY TES Mizuho USA, Inc. | LCX |
| Oct 1, 1996 | K962721 | EVIDENCE PREGNANCY TEST Saliva Diagnostic Systems | LCX |
| Sep 23, 1996 | K962888 | AFFIRM ONE-STEP HOME PREGNANCY TEST Athena Medical Corp. | LCX |
| Aug 29, 1996 | K962580 | EZ SURE ONESTEP EARLY PREGNANCY TEST Excel Scientific, Inc. | LCX |
| Jul 29, 1996 | K962521 | FACTPLUS ONE STEP PREGNANCY TEST Direct Access Diagnostics | LCX |
| Jul 23, 1996 | K962219 | QUICKSTICK ONE STEP PREGNANCY TEST(9010) Phamatech | LCX |
| Jul 10, 1996 | K962183 | BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES Armkel, LLC | LCX |
| Jun 24, 1996 | K961965 | SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc. | LCX |
| May 31, 1996 | K961712 | TBD AT-HOME PREGNANCY TEST Armkel, LLC | LCX |
| May 1, 1996 | K960733 | MINISTICK PREGNANCY TEST Vanguard Biomedical Corp. | LCX |
| Apr 29, 1996 | K960316 | CLEARBLUE EASY Unipath , Ltd., GB | LCX |
| Apr 1, 1996 | K960174 | UNIMARK MIDSTREAM PREGNANCY TEST STICK Biotech Atlantic, Inc. | LCX |
| Mar 22, 1996 | K953606 | BEST PREGNANCY TEST Ameritek, Inc. | LCX |
| Mar 19, 1996 | K960436 | SELFCARE EARLY PREGNANCY TEST Selfcare, Inc., IE | LCX |
| Mar 19, 1996 | K960117 | PLATFORM ONESTEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. | LCX |
| Mar 6, 1996 | K955903 | SELFCARE EARLY PREGNANCY TEST Cambridge Diagnostics Ireland, Ltd., IE | LCX |
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