Product code CEP
- Device name
- Radioimmunoassay, Luteinizing Hormone
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1485
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013582 | MAYBE?MOM MINI OVULATION MICROSCOPE | Maybe?Mom | 2003-01-16 |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | 2002-11-05 |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | Phamatech, Inc. | 2002-05-24 |
| K013874 | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | 2002-02-19 |
| K013323 | TCI-31 LIFELONG OVULATION TESTER | Tci New York | 2001-12-05 |
| K012252 | QUIK-CHECK OVULATION PREDICTOR | ACON Laboratories, Inc. | 2001-08-24 |
| K010244 | SURE CHECK OVULATION PREDICTOR | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | 2000-10-12 |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | Selfcare, Inc. | 1999-05-25 |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | Selfcare, Inc. | 1999-05-25 |
| K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | Phamatech | 1999-03-22 |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1998-11-18 |
| K981271 | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | 1998-06-25 |
| K974508 | DBEST ONE-STEP OVULATION TEST | Ameritek, Inc. | 1998-02-02 |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Armkel, LLC | 1997-10-27 |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | 1997-03-18 |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-20 |
| K964694 | ELECSYS LH ASSAY | Boehringer Mannheim Corp. | 1997-01-24 |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | Sealite Sciences, Inc. | 1997-01-22 |
| K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | Princeton BioMeditech Corp. | 1996-11-29 |
| K962866 | OPUS HLH | Behring Diagnostics, Inc. | 1996-08-23 |
| K962041 | ACS LH2 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 |
| K960233 | MINICLINIC OVULATION PREDICTOR | Vanguard Biomedical Corp. | 1996-04-23 |
| K961109 | ACTIVE LH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-05 |
| K953581 | FIRST RESPONSE OVULATION PREDICTOR TEST | Armkel, LLC | 1995-10-03 |
| K953063 | CONCEIVE OVULATION PREDICTOR | Quidel Corp. | 1995-08-23 |
| K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1995-07-11 |
| K951748 | COAT-A-COUNT LH IRMA | Diagnostic Products Corp. | 1995-05-15 |
| K935319 | CHEMILUMINESCENCE LH | Nichols Institute Diagnostics | 1995-04-05 |
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | Disease Detection International, Inc. | 1994-10-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850049545492 | QMedix™ | Diagnostic Automation, Inc. | 2025-12-24 |
| 14562185399711 | CL AIA-PACK LH TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 00050428296646 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2023-10-25 |
| 00036800493919 | Topcare | Topco Associates, LLC | 2022-03-07 |
| 00041260012464 | Kroger | KROGER CO., THE | 2021-08-04 |
| 00041220524549 | H.E.B | H. E. BUTT GROCERY COMPANY | 2021-06-13 |
| 00087701433634 | Good Neighbor Pharmacy | Amerisourcebergen Drug Corporation | 2020-11-11 |
| 00370797011016 | Dr. Talbot's | TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC | 2020-10-23 |
| 00810038630243 | Easy@Home Ovulation Test Strip (25 tests kit) | EASY HEALTHCARE CORPORATION | 2020-06-18 |
| 00810038630205 | Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) | EASY HEALTHCARE CORPORATION | 2020-06-18 |
| 00630414293707 | Atellica IM LH | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00311917215778 | Walgreens | WALGREEN CO. | 2020-03-25 |
| 00713733805810 | Meijer | MEIJER, INC. | 2020-02-28 |
| 00311917198873 | Walgreens | WALGREEN CO. | 2020-02-07 |
| 00810038630137 | Easy@Home Ovulation Test Strip (50 tests-bulk pack) | EASY HEALTHCARE CORPORATION | 2020-02-03 |
| 14560189210698 | ST AIA-PACK LH II | TOSOH CORPORATION | 2019-07-24 |
| 00050428605868 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2019-06-07 |
| 00050428397824 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2019-06-07 |
| 00633472601897 | Clearblue | SPD SWISS PRECISION DIAGNOSTICS GMBH | 2019-04-17 |
| 00087701738319 | Good Neighbor Pharmacy | Amerisourcebergen Drug Corporation | 2019-03-01 |
| 00041260351594 | Kroger | KROGER CO., THE | 2019-02-11 |
| 00050428356371 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2019-02-06 |
| 00681131240789 | Equate | WAL-MART STORES, INC. | 2018-10-01 |
| 00633472601200 | Clearblue | SPD SWISS PRECISION DIAGNOSTICS GMBH | 2018-05-24 |
| 00633472601347 | Clearblue | SPD SWISS PRECISION DIAGNOSTICS GMBH | 2018-05-24 |
| 00492450308636 | Up & Up | TARGET CORPORATION | 2018-02-12 |
| 00633472601026 | Clearblue | SPD SWISS PRECISION DIAGNOSTICS GMBH | 2016-11-16 |
| 10805360016015 | OvuQuick Ovulation Predictor Test | VITROLIFE INC. | 2016-09-23 |
| 10805360016039 | OvuQuick Ovulation Predictor Test | VITROLIFE INC. | 2016-09-23 |
| 00633472155642 | Clearblue Easy Ovulation Kit | SPD SWISS PRECISION DIAGNOSTICS GMBH | 2016-06-30 |