Panels › Clinical Chemistry › Product code CEP · Class 1
Radioimmunoassay, Luteinizing Hormone
Regulation 862.1485
0510(k)s in 12 months (143 all time)
0recalls in 12 months (6 all time)
3recalls that name a 510(k)
Top companies in CEP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2003 | K013582 | MAYBE?MOM MINI OVULATION MICROSCOPE Maybe?Mom | CEP |
| Nov 5, 2002 | K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST Alfa Scientific Designs, Inc. | CEP |
| May 24, 2002 | K021409 | AT HOME OVULATION TEST, MODEL 9032 Phamatech, Inc. | CEP |
| Feb 19, 2002 | K013874 | CLEARPLANE EASY OVULATION TEST Unipath , Ltd. | CEP |
| Dec 5, 2001 | K013323 | TCI-31 LIFELONG OVULATION TESTER Tci New York | CEP |
| Aug 24, 2001 | K012252 | QUIK-CHECK OVULATION PREDICTOR ACON Laboratories, Inc. | CEP |
| May 2, 2001 | K010244 | SURE CHECK OVULATION PREDICTOR Chembio Diagnostic Systems, Inc. | CEP |
| Oct 12, 2000 | K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST Selfcare, Inc. | CEP |
| May 25, 1999 | K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) Selfcare, Inc. | CEP |
| May 25, 1999 | K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) Selfcare, Inc. | CEP |
| Mar 22, 1999 | K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 Phamatech | CEP |
| Nov 18, 1998 | K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT Syntron Bioresearch, Inc. | CEP |
| Jun 25, 1998 | K981271 | CLEARPLAN EASY OVULATION TEST Unipath , Ltd., GB | CEP |
| Feb 2, 1998 | K974508 | DBEST ONE-STEP OVULATION TEST Ameritek, Inc. | CEP |
| Oct 27, 1997 | K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST Armkel, LLC | CEP |
| Mar 18, 1997 | K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT Excel Scientific, Inc. | CEP |
| Feb 20, 1997 | K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) Johnson & Johnson Clinical Diagnostics, Inc. | CEP |
| Jan 24, 1997 | K964694 | ELECSYS LH ASSAY Boehringer Mannheim Corp. | CEP |
| Jan 22, 1997 | K964925 | SEALITE SCIENCES, INC. AQUALITE LH Sealite Sciences, Inc. | CEP |
| Nov 29, 1996 | K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST Princeton BioMeditech Corp. | CEP |
| Aug 23, 1996 | K962866 | OPUS HLH Behring Diagnostics, Inc. | CEP |
| Jun 21, 1996 | K962041 | ACS LH2 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CEP |
| Apr 23, 1996 | K960233 | MINICLINIC OVULATION PREDICTOR Vanguard Biomedical Corp. | CEP |
| Apr 5, 1996 | K961109 | ACTIVE LH IRMA Diagnostic Systems Laboratories, Inc. | CEP |
| Oct 3, 1995 | K953581 | FIRST RESPONSE OVULATION PREDICTOR TEST Armkel, LLC | CEP |
| Aug 23, 1995 | K953063 | CONCEIVE OVULATION PREDICTOR Quidel Corp. | CEP |
| Jul 11, 1995 | K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT Syntron Bioresearch, Inc. | CEP |
| May 15, 1995 | K951748 | COAT-A-COUNT LH IRMA Diagnostic Products Corp. | CEP |
| Apr 5, 1995 | K935319 | CHEMILUMINESCENCE LH Nichols Institute Diagnostics | CEP |
| Oct 25, 1994 | K943252 | PRO-STEP LH OVULATION PREDICTION TEST Disease Detection International, Inc. | CEP |
| Oct 20, 1994 | K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD Dupont Medical Products | CEP |
| Oct 20, 1994 | K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH Sealite Sciences, Inc. | CEP |
| Sep 7, 1994 | K942638 | SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | CEP |
| Apr 6, 1994 | K940549 | ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY Bio-Rad Laboratories, Inc. | CEP |
| Jan 11, 1994 | K935134 | ONE STEP LH TEST Tcpi, Inc. | CEP |
| May 26, 1993 | K930306 | COBAS CORE LH EIA Roche Diagnostic Systems, Inc. | CEP |
| May 26, 1993 | K926394 | VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY Syva Co. | CEP |
| Mar 4, 1993 | K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP Princeton Biomedix | CEP |
| Feb 2, 1993 | K922944 | IMMUCHEM LH-MW ELISA Icn Biomedicals, Inc. | CEP |
| Apr 8, 1992 | K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Vitek Systems, Inc. | CEP |
| Apr 8, 1992 | K920920 | ELISA TUBE LH TEST KIT Bio Clinic Co. | CEP |
| Mar 11, 1992 | K920411 | IMMULITE HLH Cirrus Diagnostics, Inc. | CEP |
| Mar 11, 1992 | K920160 | LH GEN III SELF-TEST/CONCEIVE Quidel Corp. | CEP |
| Mar 2, 1992 | K920504 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CEP |
| Nov 7, 1991 | K913938 | OPUS(R) LH TEST SYSTEM Pb Diagnostic Systems, Inc. | CEP |
| Apr 12, 1991 | K911050 | LH IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. | CEP |
| Mar 21, 1991 | K910351 | MINICLINIC OVULATION PREDICTION TEST Vanguard Biomedical Corp. | CEP |
| Mar 19, 1991 | K910717 | PANTEX IRMA LH 1251 KIT Pantex, Div. Bio-Analysis, Inc. | CEP |
| Feb 4, 1991 | K910198 | CIBA CORNING ACS LH IMMUNOASSAY Ciba Corning Diagnostics Corp. | CEP |
| Nov 6, 1990 | K904387 | BIOCLONES ELEGANCE LH ELISA KIT Bioclone Australia Pty , Ltd. | CEP |
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