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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 Effective Date To 08/29/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
BTNX Inc. Rapid Response FSH Menopausal Test  
K052662   Follicle stimulating hormone (FSH) Endocrinology 07/12/2013
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 (midstream)  
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
IND Diagnostic INC. One Step FSH Menopausal Test (Strip)  
K052662   Follicle stimulating hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Cassette)  
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
Acon Laboratories, Inc. FSH One Step Menopause Test Strip  (Professional Use)
K041165   Follicle stimulating hormone (FSH) Endocrinology 08/24/2005

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