| MAYBE?MOM MINI OVULATION MICROSCOPE (K013582) | Maybe?Mom | 2003-01-16 |
| INSTANT-VIEW LH OVULATION PREDICTING TEST (K022829) | Alfa Scientific Designs, Inc. | 2002-11-05 |
| AT HOME OVULATION TEST, MODEL 9032 (K021409) | Phamatech, Inc. | 2002-05-24 |
| CLEARPLANE EASY OVULATION TEST (K013874) | Unipath , Ltd. | 2002-02-19 |
| TCI-31 LIFELONG OVULATION TESTER (K013323) | Tci New York | 2001-12-05 |
| QUIK-CHECK OVULATION PREDICTOR (K012252) | ACON Laboratories, Inc. | 2001-08-24 |
| SURE CHECK OVULATION PREDICTOR (K010244) | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| INVERNESS MEDICAL OVULATION PREDICTOR TEST (K002867) | Selfcare, Inc. | 2000-10-12 |
| EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) (K991466) | Selfcare, Inc. | 1999-05-25 |
| EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) (K991386) | Selfcare, Inc. | 1999-05-25 |
| OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 (K990249) | Phamatech | 1999-03-22 |
| BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113) | Syntron Bioresearch, Inc. | 1998-11-18 |
| CLEARPLAN EASY OVULATION TEST (K981271) | Unipath , Ltd. | 1998-06-25 |
| DBEST ONE-STEP OVULATION TEST (K974508) | Ameritek, Inc. | 1998-02-02 |
| TBD* ONE-STEP OVULATION PREDICTOR TEST (K973310) | Armkel, LLC | 1997-10-27 |
| EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT (K970467) | Excel Scientific, Inc. | 1997-03-18 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) (K964982) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-20 |
| ELECSYS LH ASSAY (K964694) | Boehringer Mannheim Corp. | 1997-01-24 |
| SEALITE SCIENCES, INC. AQUALITE LH (K964925) | Sealite Sciences, Inc. | 1997-01-22 |
| OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST (K963693) | Princeton BioMeditech Corp. | 1996-11-29 |
| OPUS HLH (K962866) | Behring Diagnostics, Inc. | 1996-08-23 |
| ACS LH2 IMMUNOASSAY (K962041) | Ciba Corning Diagnostics Corp. | 1996-06-21 |
| MINICLINIC OVULATION PREDICTOR (K960233) | Vanguard Biomedical Corp. | 1996-04-23 |
| ACTIVE LH IRMA (K961109) | Diagnostic Systems Laboratories, Inc. | 1996-04-05 |
| FIRST RESPONSE OVULATION PREDICTOR TEST (K953581) | Armkel, LLC | 1995-10-03 |
| CONCEIVE OVULATION PREDICTOR (K953063) | Quidel Corp. | 1995-08-23 |
| BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT (K951538) | Syntron Bioresearch, Inc. | 1995-07-11 |
| COAT-A-COUNT LH IRMA (K951748) | Diagnostic Products Corp. | 1995-05-15 |
| CHEMILUMINESCENCE LH (K935319) | Nichols Institute Diagnostics | 1995-04-05 |
| PRO-STEP LH OVULATION PREDICTION TEST (K943252) | Disease Detection International, Inc. | 1994-10-25 |
| SEALITE SCIENCE, INC. AQUALITE(R) LH (K943188) | Sealite Sciences, Inc. | 1994-10-20 |
| DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (K943996) | Dupont Medical Products | 1994-10-20 |
| SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT (K942638) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-09-07 |
| ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY (K940549) | Bio-Rad Laboratories, Inc. | 1994-04-06 |
| ONE STEP LH TEST (K935134) | Tcpi, Inc. | 1994-01-11 |
| VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY (K926394) | Syva Co. | 1993-05-26 |
| COBAS CORE LH EIA (K930306) | Roche Diagnostic Systems, Inc. | 1993-05-26 |
| OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (K930185) | Princeton Biomedix | 1993-03-04 |
| IMMUCHEM LH-MW ELISA (K922944) | Icn Biomedicals, Inc. | 1993-02-02 |
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921176) | Vitek Systems, Inc. | 1992-04-08 |
| ELISA TUBE LH TEST KIT (K920920) | Bio Clinic Co. | 1992-04-08 |
| LH GEN III SELF-TEST/CONCEIVE (K920160) | Quidel Corp. | 1992-03-11 |
| IMMULITE HLH (K920411) | Cirrus Diagnostics, Inc. | 1992-03-11 |
| MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K920504) | Medix Biotech, Inc. | 1992-03-02 |
| OPUS(R) LH TEST SYSTEM (K913938) | Pb Diagnostic Systems, Inc. | 1991-11-07 |
| LH IRMA IMMUNOMAG (K911050) | Pantex, Div. Bio-Analysis, Inc. | 1991-04-12 |
| MINICLINIC OVULATION PREDICTION TEST (K910351) | Vanguard Biomedical Corp. | 1991-03-21 |
| PANTEX IRMA LH 1251 KIT (K910717) | Pantex, Div. Bio-Analysis, Inc. | 1991-03-19 |
| CIBA CORNING ACS LH IMMUNOASSAY (K910198) | Ciba Corning Diagnostics Corp. | 1991-02-04 |
| BIOCLONES ELEGANCE LH ELISA KIT (K904387) | Bioclone Australia Pty , Ltd. | 1990-11-06 |
| MILENIA (TM) LH (K902786) | Diagnostic Products Corp. | 1990-10-12 |
| IMMUNOCORP LH IRMA COATED TUBE (K903052) | Immunocorp Sciences, Inc. | 1990-08-29 |
| LUMATAG(TM) LH DIAGNOSTIC KIT (K902443) | London Diagnostics, Inc. | 1990-08-02 |
| MODIFIED OVUGEN (K902208) | Biogenex Laboratories | 1990-07-17 |
| CIBA CORNING MAGIC LITE LH IMMUNOASSAY (K902398) | Ciba Corning Diagnostics Corp. | 1990-06-28 |
| ENZYMUN TEST(R) LH (K900779) | Boehringer Mannheim Corp. | 1990-04-03 |
| FIAGEN(TM) HLH.S (K900621) | Cyberfluor, Inc. | 1990-03-01 |
| LUTEINIZING HORMONE-EIA-XT (K896866) | In Vitro Diagnostics, Inc. | 1990-02-13 |
| MODIFIED LH ENZYME IMMUNOASSAY TEST KIT (K896642) | Medix Biotech, Inc. | 1990-01-30 |
| TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT (K895094) | Hybritech, Inc. | 1989-10-31 |
| CLEARPLAN EASY (K894579) | Unipath , Ltd. | 1989-10-12 |
| LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST (K894279) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-08-15 |
| MINICLINIC OVULATION PREDICTION TEST (K891762) | Vanguard Biomedical Corp. | 1989-07-20 |
| SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY (K893605) | Serono-Baker Diagnostics, Inc. | 1989-06-20 |
| ABBOTT OVULATION PREDICTOR TEST (K890510) | Abbott Laboratories | 1989-03-24 |
| DELFIA HLH SPEC KIT (K883814) | Pharmacia, Inc. | 1989-03-08 |
| COTUBE LH IRMA ASSAY (K884498) | Bio-Rad | 1988-12-22 |
| FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST (K883530) | Tambrands, Inc. | 1988-12-19 |
| ABBOTT IMX LH (K884138) | Abbott Laboratories | 1988-11-29 |
| LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (K882340) | Serono Diagnostics, Inc. | 1988-08-08 |
| PHASE II LH KIT (K882252) | Vitek Systems, Inc. | 1988-08-04 |
| AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST (K880933) | Amersham Corp. | 1988-07-28 |
| ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY (K881124) | Nichols Institute Diagnostics | 1988-04-18 |
| SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY (K880758) | Boots-Celltech Diagnostics, Inc. | 1988-04-18 |
| FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 (K874624) | Cyberfluor, Inc. | 1988-01-11 |
| IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 (K874032) | Diagnostic Products Corp. | 1987-12-30 |
| O.P.T.(TM) OVULATION PREDICTION TEST (K870584) | Warner-Lambert Co. | 1987-11-25 |
| OVUGEN SURETEST (K873534) | Biogenex Laboratories | 1987-11-23 |
| MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K873668) | Medix Biotech, Inc. | 1987-10-07 |
| ANSWER OVULATION TEST KIT (K871241) | Armkel, LLC | 1987-10-02 |
| LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (K873186) | Serono Diagnostics, Inc. | 1987-09-29 |
| STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (K873052) | American Dade | 1987-09-14 |
| TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY (K872131) | Hybritech, Inc. | 1987-08-25 |
| CLEARPLAN (K871332) | Unipath , Ltd. | 1987-08-05 |
| LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE (K872727) | Serono Diagnostics, Inc. | 1987-08-05 |
| OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (K871726) | Monoclonal Antibodies, Inc. | 1987-07-27 |
| MICROCHECK LH OVULATION TEST (K871602) | Syntron Bioresearch, Inc. | 1987-06-11 |
| DPC COAT-A-COUNT IRMA LH KIT (K863934) | Diagnostic Products Corp. | 1987-02-06 |
| UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE (K863442) | United Biotech, Inc. | 1987-02-04 |
| CANWEST OVU-BLUE (K862055) | Canwest Medictex, Inc. | 1987-01-06 |
| LUTEINIZING HORMONE (LH-IRMA) RIA KIT (K864144) | Immuchem Corp. | 1986-11-24 |
| TERUMO SENSIBEAD(TM) EIA HLH KIT (K863929) | Terumo Medical Corp. | 1986-11-13 |
| ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM (K863679) | Nichols Institute Diagnostics | 1986-10-16 |
| RIGHT-DAY OVULATION HOME TEST (K861354) | Leeco Diagnostics, Inc. | 1986-09-16 |
| FORETEL, COLOR OVULATION TEST (K860828) | Nms Pharmaceuticals, Inc. | 1986-08-04 |
| RIGHT-DAY URINARY LH (EIA) (K860538) | Leeco Diagnostics, Inc. | 1986-07-29 |
| MODIFIED COTROPIN RADIOIMMUNOASSAY KIT (K862180) | Clinetics Corp. | 1986-07-07 |
| TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT (K860984) | Hybritech, Inc. | 1986-04-29 |
| VISI-CHECK HLH TEST MONOCLONAL (K860334) | Bioclinical Systems, Inc. | 1986-04-21 |
| MICRO-ELISA HLH TEST KIT MONOCLONAL (K860333) | Bioclinical Systems, Inc. | 1986-04-21 |