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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Follicle Stimulating Hormone (FSH) Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
QuantRx Biomedical QuantRx Female Fertility Test  
K070484 Follicle Stimulating Hormone (FSH) Endocrinology 10/29/2007
Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device  (Professional Use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006
RAC Medical Clarity FSH One Step Menopause Test Device  (Professional Use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006
IND Diagnostic INC. One Step FSH Menopausal Test (Cassette)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (midstream)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Strip)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test  (Professional Use)
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test  (Professional Use)
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
Acon Laboratories, Inc. FSH One Step Menopause Test Device  (Professional Use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 08/24/2005
Acon Laboratories, Inc. FSH One Step Menopause Test Strip  (Professional Use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 08/24/2005

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