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NGE — Test, Luteinizing Hormone (Lh), Over The Counter Class I

FDA Device Classification

Classification Details

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K020808pheromone sciencesFERTILITE OVSeptember 23, 2002
K990223unipathMODIFICATION OF CLEARPLAN EASY FERTILITY MONITORFebruary 24, 1999
K981207unipathCLEARPLAN EASY FERTILITY MONITOROctober 28, 1998
K973860conception technologyOVULON MONITORJanuary 7, 1998
K863121micron technologyPEAK OVULATION PREDICTOROctober 14, 1986
K850579zetekCUE FERTILITY MONITORMarch 22, 1985