CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name UNIPATH CLEARPLAN EASY FERTILITY MONITOR   Document Number K981207 Analyte Name Estrone-3 Glucuronide Analyte Specialty Endocrinology Complexity WAIVED Effective Date 07/17/2000 Device Classification Name device, fertility diagnostic, proceptive 510(k) Number K981207 Device Name CLEARPLAN EASY FERTILITY MONITOR Applicant UNIPATH LTD. priory business park bedford,  Contact louise roberts Classification Product Code LHD   Subsequent Product Code CEP   Date Received 04/02/1998 Decision Date 10/28/1998 Decision substantially equivalent (SE) Classification Advisory Committee Obstetrics/Gynecology Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Statement/purged 510(k) statement statement Type Traditional Reviewed by Third Party No Expedited Review No