| INVERNESS MEDICAL EARLY PREGNANCY TEST (K013907) | Cambridge Diagnostics Ireland, Ltd. | 2001-12-18 |
| CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K013372) | Unipath , Ltd. | 2001-11-09 |
| SURE CHECK PREGNANCY TEST (K011551) | Chembio Diagnostic Systems, Inc. | 2001-08-14 |
| QUIK-CHECK HOME PREGNANCY TEST (K012215) | ACON Laboratories, Inc. | 2001-08-07 |
| INVERNESS MEDICAL EARLY PREGNANCY TEST (K002049) | Selfcare, Inc. | 2000-07-27 |
| ACON ONE STEP HOME PREGNANCY TEST STRIP (K993483) | ACON Laboratories, Inc. | 2000-01-20 |
| FIRST RESPONSE 1-STEP PREGNANCY (K992232) | Armkel, LLC | 1999-12-21 |
| CLEARPLAN EASY II HOME PREGNANCY TEST (K993333) | Unipath , Ltd. | 1999-12-16 |
| AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 (K993141) | Phamatech | 1999-11-08 |
| ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY (K991369) | Germaine Laboratories, Inc. | 1999-05-10 |
| SAS HCG-CHECK (K991193) | Sa Scientific, Inc. | 1999-05-04 |
| CLEARPLAN EASY HOME PREGNANCY TEST (K990262) | Unipath , Ltd. | 1999-04-07 |
| OSOM CARD PREGNANCY TEST, MODEL 103 (K990576) | Wyntek Diagnostics, Inc. | 1999-03-09 |
| FACT PLUS ONE STEP PREGNANCY TEST (K990373) | Abbott Laboratories | 1999-02-22 |
| INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST (K984075) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| ACON MIDSTREAM PREGNANCY TEST (K983090) | ACON Laboratories, Inc. | 1998-11-18 |
| QUICK & SURE ONESTEP HOME PREGNANCY TEST (K981892) | Abacus Diagnostics | 1998-08-18 |
| QUIDEL HOME PREGNANCY TEST (K981722) | Quidel Corp. | 1998-06-03 |
| ONE STEP MIDSTREAM HCG PREGNANCY TEST (K974059) | International Newtech Development, Inc. | 1998-04-09 |
| QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 (K980532) | Phamatech | 1998-03-11 |
| BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST (K974821) | Quidel Corp. | 1998-01-26 |
| CHOICE ACCU-TEST PREGNANCY TEST KIT (K974154) | Sa Scientific, Inc. | 1997-12-19 |
| SIGNAL PREGNANCY TEST KIT (K974021) | Sa Scientific, Inc. | 1997-12-19 |
| QUICK CARD HCG ONE STEP PREGNANCY TEST (K973570) | Phamatech | 1997-10-31 |
| BRAND NAME *1-STEP PREGNANCY (K973352) | Armkel, LLC | 1997-10-27 |
| FIRST SIGN (K973208) | Texas Immunology, Inc. | 1997-10-20 |
| QUICKSTICK ONE STEP HCG PREGNANCY TEST (K972682) | Phamatech | 1997-08-01 |
| EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST (K971286) | Excel Scientific, Inc. | 1997-05-08 |
| EZ SURE URINE DIPSTICK PREGNANCY HOME TEST (K970425) | Excel Scientific, Inc. | 1997-03-06 |
| ADVANCED QUALITY PREGNANCY TEST (K970008) | Bionike, Inc. | 1997-02-18 |
| PERFECTA PREGNANCY TEST (K965184) | Wyntek Diagnostics, Inc. | 1997-02-04 |
| ABBOTT ADVISOR ONE-STEP PREGNANCY TEST (K970082) | Abbott Laboratories | 1997-01-24 |
| MIDSTREAM ONESTEP PREGNANCY HOME TEST (K963341) | Syntron Bioresearch, Inc. | 1996-12-02 |
| FACT PLUS PREGNANCY TEST (K964108) | Direct Access Diagnostics | 1996-11-18 |
| NATURALE HCG PREGNANCY TES (K964002) | Mizuho USA, Inc. | 1996-11-07 |
| EVIDENCE PREGNANCY TEST (K962721) | Saliva Diagnostic Systems | 1996-10-01 |
| AFFIRM ONE-STEP HOME PREGNANCY TEST (K962888) | Athena Medical Corp. | 1996-09-23 |
| EZ SURE ONESTEP EARLY PREGNANCY TEST (K962580) | Excel Scientific, Inc. | 1996-08-29 |
| FACTPLUS ONE STEP PREGNANCY TEST (K962521) | Direct Access Diagnostics | 1996-07-29 |
| QUICKSTICK ONE STEP PREGNANCY TEST(9010) (K962219) | Phamatech | 1996-07-23 |
| BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES (K962183) | Armkel, LLC | 1996-07-10 |
| SURE CHECK PREGNANCY TEST (K961965) | Chembio Diagnostic Systems, Inc. | 1996-06-24 |
| TBD AT-HOME PREGNANCY TEST (K961712) | Armkel, LLC | 1996-05-31 |
| MINISTICK PREGNANCY TEST (K960733) | Vanguard Biomedical Corp. | 1996-05-01 |
| CLEARBLUE EASY (K960316) | Unipath , Ltd. | 1996-04-29 |
| UNIMARK MIDSTREAM PREGNANCY TEST STICK (K960174) | Biotech Atlantic, Inc. | 1996-04-01 |
| BEST PREGNANCY TEST (K953606) | Ameritek, Inc. | 1996-03-22 |
| SELFCARE EARLY PREGNANCY TEST (K960436) | Selfcare, Inc. | 1996-03-19 |
| PLATFORM ONESTEP PREGNANCY HOME TEST (K960117) | Syntron Bioresearch, Inc. | 1996-03-19 |
| SELFCARE EARLY PREGNANCY TEST (K955903) | Cambridge Diagnostics Ireland, Ltd. | 1996-03-06 |
| OSOM PREGNANCY TEST (K954178) | Wyntek Diagnostics, Inc. | 1995-10-23 |
| CAMEO HOME PREGNANCY TEST (K954364) | Quidel Corp. | 1995-10-13 |
| HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY (K950354) | Ml Strategies, Inc. | 1995-07-19 |
| LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG (K945514) | Princeton BioMeditech Corp. | 1995-02-10 |
| ADVANCE(R) PREGNANCY TEST (K945846) | Advanced Care Products | 1995-01-27 |
| HCG MIDSTREAM PREGNANCY TEST (K945568) | Mizuho USA, Inc. | 1995-01-17 |
| HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE (K941765) | Tcpi, Inc. | 1994-10-20 |
| PREGNANCY CHECK (K941355) | Sa Scientific, Inc. | 1994-07-06 |
| BODYWISE PREGNANCEY TEST (K941771) | Charlton Assoc. | 1994-07-06 |
| PREDICTOR HOME PREGNANCY TEST (K940637) | Organon Teknika Corp. | 1994-06-02 |
| ANI BIOCARD(TM) HCG TEST (K933794) | Canadian Bioclinical, Ltd. | 1994-05-19 |
| EVATEST STRIP (K936013) | Boehringer Mannheim Italia Spa | 1994-02-25 |
| ADVANCE PREGNANCY TEST MODIFICATION (K934516) | Ortho Pharmaceutical Corp. | 1994-02-24 |
| HCG PREGNANCY ONE STEP TEST STRIP (K934830) | Tcpi, Inc. | 1993-12-02 |
| HCG MIDSTREAM PREGNANCY TEST (K931997) | Mizuho USA, Inc. | 1993-09-10 |
| BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST (K930488) | Syntron Bioresearch, Inc. | 1993-04-06 |
| PRECISE PREGNANCY (K930640) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-03-18 |
| LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (K926308) | Princeton Biomedix | 1993-01-26 |
| PREGNAGEN 1-STEP PREGNANCY TEST (K925189) | Biogenex Laboratories | 1993-01-06 |
| CONCEIVE ONE-STEP PREGNANCY TEST (K925096) | Quidel Corp. | 1992-12-28 |
| SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST (K921099) | Syntron Bioresearch, Inc. | 1992-05-29 |
| PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG (K921012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-08 |
| ADVANCE(R) PREGNANCY TEST (K914990) | Ortho Pharmaceutical Corp. | 1991-12-23 |
| HOMECLINIC ONE STEP PREGNANCY TEST (K914254) | Vanguard Biomedical Corp. | 1991-10-17 |
| FIRST RESPONSE(R) ONE-STEP (K914304) | Armkel, LLC | 1991-10-17 |
| QUIKPAC-II ONE STEP PREGNANCY HOME TEST (K912316) | Syntron Bioresearch, Inc. | 1991-07-24 |
| CLEARBLUE EASY (K911566) | Unipath , Ltd. | 1991-05-06 |
| CLEARBLUE EASY (K905742) | Unipath , Ltd. | 1991-02-13 |
| ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST (K904782) | Carter Products | 1990-12-06 |
| ABBOTT MODIFIED FACT PLUS PREGNANCY TEST (K901981) | Abbott Laboratories | 1990-08-02 |
| PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT (K896482) | Pacific Biotech, Inc. | 1990-03-06 |
| MODIFIED HOMECLINIC PREGNANCY TEST (K895560) | Vanguard Biomedical Corp. | 1989-11-13 |
| C&T PREGNANCY TEST KIT (K884489) | Healthcheck Corp. | 1989-03-08 |
| PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST (K883430) | Disease Detection International, Inc. | 1989-01-30 |
| HOME CLINIC PREGNANCY TEST (K883826) | Vanguard Biomedical Corp. | 1988-11-29 |
| DISCOVER(R) (K882232) | Carter Products | 1988-10-25 |
| BLUE DOT(TM) TEST FOR PREGNANCY (K882588) | V-Tech, Inc. | 1988-10-06 |
| CLEARBLUE EASY (K882416) | Unipath , Ltd. | 1988-07-28 |
| ADVANCE* AND DAISY* PREGNANCY TEST (K880472) | Advanced Care Products | 1988-05-16 |
| FIRST RESPONSE 5 MINUTE PREGNANCY TEST (K874823) | Tambrands, Inc. | 1988-04-05 |
| LEECO PREGNASTICK (EIA) CATALOG #003 (K880069) | Leeco Diagnostics, Inc. | 1988-02-11 |
| SYNTRON BIORESEARCH U-TEST PREGNANCY TEST (K874248) | Syntron Bioresearch, Inc. | 1987-11-04 |
| ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST (K871601) | Advanced Care Products | 1987-08-26 |
| ABBOTT BIOTELL PREGNANCY TEST (K871996) | Abbott Laboratories | 1987-08-18 |
| CARDS(TM) - EARLY PREGNANCY TEST (K863341) | Pacific Biotech, Inc. | 1987-01-14 |
| VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (K863999) | Leeco Diagnostics, Inc. | 1987-01-09 |
| CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) (K864373) | Unipath , Ltd. | 1987-01-09 |
| TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE (K863841) | Hybritech, Inc. | 1986-12-22 |
| QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION) (K862207) | Quidel Corp. | 1986-06-17 |
| PTK PLUS. HOME PREGNANCY TEST (K861946) | Healthcheck Corp. | 1986-06-16 |