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CEP — Radioimmunoassay, Luteinizing Hormone Class I

FDA Device Classification

Classification Details

Product Code
CEP
Device Class
Class I
Regulation Number
862.1485
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K013582maybe?momMAYBE?MOM MINI OVULATION MICROSCOPEJanuary 16, 2003
K022829alfa scientific designsINSTANT-VIEW LH OVULATION PREDICTING TESTNovember 5, 2002
K021409phamatechAT HOME OVULATION TEST, MODEL 9032May 24, 2002
K013874unipathCLEARPLANE EASY OVULATION TESTFebruary 19, 2002
K013323tci new yorkTCI-31 LIFELONG OVULATION TESTERDecember 5, 2001
K012252acon laboratoriesQUIK-CHECK OVULATION PREDICTORAugust 24, 2001
K010244chembio diagnostic systemsSURE CHECK OVULATION PREDICTORMay 2, 2001
K002867selfcareINVERNESS MEDICAL OVULATION PREDICTOR TESTOctober 12, 2000
K991386selfcareEARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATIMay 25, 1999
K991466selfcareEARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OMay 25, 1999
K990249phamatechOVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODMarch 22, 1999
K983113syntron bioresearchBESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KITNovember 18, 1998
K981271unipathCLEARPLAN EASY OVULATION TESTJune 25, 1998
K974508ameritekDBEST ONE-STEP OVULATION TESTFebruary 2, 1998
K973310armkelTBD* ONE-STEP OVULATION PREDICTOR TESTOctober 27, 1997
K970467excel scientificEZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KITMarch 18, 1997
K964982johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS February 20, 1997
K964694boehringer mannheimELECSYS LH ASSAYJanuary 24, 1997
K964925sealite sciencesSEALITE SCIENCES, INC. AQUALITE LHJanuary 22, 1997
K963693princeton biomeditechOVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TESTNovember 29, 1996