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NGA — Test, Follicle Stimulating Hormone (Fsh), Over The Counter Class I

FDA Device Classification

Classification Details

Product Code
NGA
Device Class
Class I
Regulation Number
862.1300
Submission Type
Review Panel
TX
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K070484quantrx biomedical corporationQUANTRX FEMALE FERTILITY TESTOctober 22, 2007
K032002genosisFERTELL FEMALE FERTILITY TESTOctober 30, 2003