FDA 510(k) Applications for Medical Device Product Code "CEP"
(Radioimmunoassay, Luteinizing Hormone)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K012252 | ACON LABORATORIES, INC. | QUIK-CHECK OVULATION PREDICTOR | 08/24/2001 |
| K022829 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW LH OVULATION PREDICTING TEST | 11/05/2002 |
| K974508 | AMERITEK, INC. | DBEST ONE-STEP OVULATION TEST | 02/02/1998 |
| K973310 | ARMKEL, LLC. | TBD* ONE-STEP OVULATION PREDICTOR TEST | 10/27/1997 |
| K962866 | BEHRING DIAGNOSTICS, INC. | OPUS HLH | 08/23/1996 |
| K964694 | BOEHRINGER MANNHEIM CORP. | ELECSYS LH ASSAY | 01/24/1997 |
| K010244 | Chembio Diagnostic Systems, Inc. | SURE CHECK OVULATION PREDICTOR | 05/02/2001 |
| K962041 | CIBA CORNING DIAGNOSTICS CORP. | ACS LH2 IMMUNOASSAY | 06/21/1996 |
| K961109 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE LH IRMA | 04/05/1996 |
| K970467 | EXCEL SCIENTIFIC, INC. | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | 03/18/1997 |
| K964982 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | 02/20/1997 |
| K013582 | MAYBE?MOM | MAYBE?MOM MINI OVULATION MICROSCOPE | 01/16/2003 |
| K990249 | PHAMATECH | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | 03/22/1999 |
| K021409 | PHAMATECH INC. | AT HOME OVULATION TEST, MODEL 9032 | 05/24/2002 |
| K963693 | PRINCETON BIOMEDITECH CORP. | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | 11/29/1996 |
| K964925 | SEALITE SCIENCES, INC. | SEALITE SCIENCES, INC. AQUALITE LH | 01/22/1997 |
| K991466 | SELFCARE, INC. | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | 05/25/1999 |
| K991386 | SELFCARE, INC. | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | 05/25/1999 |
| K002867 | SELFCARE, INC. | INVERNESS MEDICAL OVULATION PREDICTOR TEST | 10/12/2000 |
| K983113 | SYNTRON BIORESEARCH, INC. | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | 11/18/1998 |
| K013323 | TCI NEW YORK | TCI-31 LIFELONG OVULATION TESTER | 12/05/2001 |
| K981271 | UNIPATH LTD. | CLEARPLAN EASY OVULATION TEST | 06/25/1998 |
| K013874 | UNIPATH LTD. | CLEARPLANE EASY OVULATION TEST | 02/19/2002 |
| K960233 | VANGUARD BIOMEDICAL CORP. | MINICLINIC OVULATION PREDICTOR | 04/23/1996 |
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