FDA Product Code
FDA Product Code CEP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1485
510(k) Clearances — 143 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013582 | MAYBE?MOM MINI OVULATION MICROSCOPE | Maybe?Mom | 2003-01-16 | Traditional | PDF ↗ |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | 2002-11-05 | Abbreviated | PDF ↗ |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | Phamatech, Inc. | 2002-05-24 | Special | PDF ↗ |
| K013874 | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | 2002-02-19 | Traditional | PDF ↗ |
| K013323 | TCI-31 LIFELONG OVULATION TESTER | Tci New York | 2001-12-05 | Traditional | PDF ↗ |
| K012252 | QUIK-CHECK OVULATION PREDICTOR | ACON Laboratories, Inc. | 2001-08-24 | Traditional | PDF ↗ |
| K010244 | SURE CHECK OVULATION PREDICTOR | Chembio Diagnostic Systems, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | 2000-10-12 | Special | PDF ↗ |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | Selfcare, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | Selfcare, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | Phamatech | 1999-03-22 | Traditional | PDF ↗ |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K981271 | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | 1998-06-25 | Traditional | PDF ↗ |
| K974508 | DBEST ONE-STEP OVULATION TEST | Ameritek, Inc. | 1998-02-02 | Traditional | PDF ↗ |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Armkel, LLC | 1997-10-27 | Traditional | PDF ↗ |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K964694 | ELECSYS LH ASSAY | Boehringer Mannheim Corp. | 1997-01-24 | Traditional | PDF ↗ |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | Sealite Sciences, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | Princeton BioMeditech Corp. | 1996-11-29 | Traditional | PDF ↗ |
| K962866 | OPUS HLH | Behring Diagnostics, Inc. | 1996-08-23 | Traditional | PDF ↗ |
| K962041 | ACS LH2 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 | Traditional | PDF ↗ |
| K960233 | MINICLINIC OVULATION PREDICTOR | Vanguard Biomedical Corp. | 1996-04-23 | Traditional | PDF ↗ |
| K961109 | ACTIVE LH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K953581 | FIRST RESPONSE OVULATION PREDICTOR TEST | Armkel, LLC | 1995-10-03 | Traditional | PDF ↗ |
| K953063 | CONCEIVE OVULATION PREDICTOR | Quidel Corp. | 1995-08-23 | Traditional | PDF ↗ |
| K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K951748 | COAT-A-COUNT LH IRMA | Diagnostic Products Corp. | 1995-05-15 | Traditional | PDF ↗ |
| K935319 | CHEMILUMINESCENCE LH | Nichols Institute Diagnostics | 1995-04-05 | Traditional | PDF ↗ |
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | Disease Detection International, Inc. | 1994-10-25 | Traditional | PDF ↗ |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | Dupont Medical Products | 1994-10-20 | Traditional | PDF ↗ |
| K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH | Sealite Sciences, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K942638 | SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-09-07 | Traditional | PDF ↗ |
| K940549 | ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | 1994-04-06 | Traditional | PDF ↗ |
| K935134 | ONE STEP LH TEST | Tcpi, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K930306 | COBAS CORE LH EIA | Roche Diagnostic Systems, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K926394 | VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY | Syva Co. | 1993-05-26 | Traditional | PDF ↗ |
| K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | Princeton Biomedix | 1993-03-04 | Traditional | PDF ↗ |
| K922944 | IMMUCHEM LH-MW ELISA | Icn Biomedicals, Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K920920 | ELISA TUBE LH TEST KIT | Bio Clinic Co. | 1992-04-08 | Traditional | PDF ↗ |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Vitek Systems, Inc. | 1992-04-08 | Traditional | PDF ↗ |
| K920411 | IMMULITE HLH | Cirrus Diagnostics, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K920160 | LH GEN III SELF-TEST/CONCEIVE | Quidel Corp. | 1992-03-11 | Traditional | PDF ↗ |
| K920504 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K913938 | OPUS(R) LH TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K911050 | LH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K910351 | MINICLINIC OVULATION PREDICTION TEST | Vanguard Biomedical Corp. | 1991-03-21 | Traditional | PDF ↗ |
| K910717 | PANTEX IRMA LH 1251 KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K910198 | CIBA CORNING ACS LH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-02-04 | Traditional | PDF ↗ |
| K904387 | BIOCLONES ELEGANCE LH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-11-06 | Traditional | PDF ↗ |
| K902786 | MILENIA (TM) LH | Diagnostic Products Corp. | 1990-10-12 | Traditional | PDF ↗ |
| K903052 | IMMUNOCORP LH IRMA COATED TUBE | Immunocorp Sciences, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K902443 | LUMATAG(TM) LH DIAGNOSTIC KIT | London Diagnostics, Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K902208 | MODIFIED OVUGEN | Biogenex Laboratories | 1990-07-17 | Traditional | PDF ↗ |
| K902398 | CIBA CORNING MAGIC LITE LH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-06-28 | Traditional | PDF ↗ |
| K900779 | ENZYMUN TEST(R) LH | Boehringer Mannheim Corp. | 1990-04-03 | Traditional | PDF ↗ |
| K900621 | FIAGEN(TM) HLH.S | Cyberfluor, Inc. | 1990-03-01 | Traditional | PDF ↗ |
| K896866 | LUTEINIZING HORMONE-EIA-XT | In Vitro Diagnostics, Inc. | 1990-02-13 | Traditional | PDF ↗ |
| K896642 | MODIFIED LH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1990-01-30 | Traditional | PDF ↗ |
| K895094 | TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT | Hybritech, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K894579 | CLEARPLAN EASY | Unipath , Ltd. | 1989-10-12 | Traditional | PDF ↗ |
| K894279 | LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-08-15 | Traditional | PDF ↗ |
| K891762 | MINICLINIC OVULATION PREDICTION TEST | Vanguard Biomedical Corp. | 1989-07-20 | Traditional | PDF ↗ |
| K893605 | SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-06-20 | Traditional | PDF ↗ |
| K890510 | ABBOTT OVULATION PREDICTOR TEST | Abbott Laboratories | 1989-03-24 | Traditional | PDF ↗ |
| K883814 | DELFIA HLH SPEC KIT | Pharmacia, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K884498 | COTUBE LH IRMA ASSAY | Bio-Rad | 1988-12-22 | Traditional | PDF ↗ |
| K883530 | FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST | Tambrands, Inc. | 1988-12-19 | Traditional | PDF ↗ |
| K884138 | ABBOTT IMX LH | Abbott Laboratories | 1988-11-29 | Traditional | PDF ↗ |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | Serono Diagnostics, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K882252 | PHASE II LH KIT | Vitek Systems, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K880933 | AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST | Amersham Corp. | 1988-07-28 | Traditional | PDF ↗ |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | Boots-Celltech Diagnostics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K881124 | ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY | Nichols Institute Diagnostics | 1988-04-18 | Traditional | PDF ↗ |
| K874624 | FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 | Cyberfluor, Inc. | 1988-01-11 | Traditional | PDF ↗ |
| K874032 | IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 | Diagnostic Products Corp. | 1987-12-30 | Traditional | PDF ↗ |
| K870584 | O.P.T.(TM) OVULATION PREDICTION TEST | Warner-Lambert Co. | 1987-11-25 | Traditional | PDF ↗ |
| K873534 | OVUGEN SURETEST | Biogenex Laboratories | 1987-11-23 | Traditional | PDF ↗ |
| K873668 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K871241 | ANSWER OVULATION TEST KIT | Armkel, LLC | 1987-10-02 | Traditional | PDF ↗ |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | Serono Diagnostics, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1987-09-14 | Traditional | PDF ↗ |
| K872131 | TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-08-25 | Traditional | PDF ↗ |
| K871332 | CLEARPLAN | Unipath , Ltd. | 1987-08-05 | Traditional | PDF ↗ |
| K872727 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE | Serono Diagnostics, Inc. | 1987-08-05 | Traditional | PDF ↗ |
| K871726 | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) | Monoclonal Antibodies, Inc. | 1987-07-27 | Traditional | PDF ↗ |
| K871602 | MICROCHECK LH OVULATION TEST | Syntron Bioresearch, Inc. | 1987-06-11 | Traditional | PDF ↗ |
| K863934 | DPC COAT-A-COUNT IRMA LH KIT | Diagnostic Products Corp. | 1987-02-06 | Traditional | PDF ↗ |
| K863442 | UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE | United Biotech, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K862055 | CANWEST OVU-BLUE | Canwest Medictex, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT | Immuchem Corp. | 1986-11-24 | Traditional | PDF ↗ |
| K863929 | TERUMO SENSIBEAD(TM) EIA HLH KIT | Terumo Medical Corp. | 1986-11-13 | Traditional | PDF ↗ |
| K863679 | ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1986-10-16 | Traditional | PDF ↗ |
| K861354 | RIGHT-DAY OVULATION HOME TEST | Leeco Diagnostics, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K860828 | FORETEL, COLOR OVULATION TEST | Nms Pharmaceuticals, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K860538 | RIGHT-DAY URINARY LH (EIA) | Leeco Diagnostics, Inc. | 1986-07-29 | Traditional | PDF ↗ |
| K862180 | MODIFIED COTROPIN RADIOIMMUNOASSAY KIT | Clinetics Corp. | 1986-07-07 | Traditional | PDF ↗ |
| K860984 | TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT | Hybritech, Inc. | 1986-04-29 | Traditional | PDF ↗ |
| K860334 | VISI-CHECK HLH TEST MONOCLONAL | Bioclinical Systems, Inc. | 1986-04-21 | Traditional | PDF ↗ |
| K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL | Bioclinical Systems, Inc. | 1986-04-21 | Traditional | PDF ↗ |
Product code CEP · Class I · Clinical Chemistry. Data: openFDA.