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510(k) K032002

FERTELL FEMALE FERTILITY TEST by Genosis, Inc. — Product Code NGA

K032002 is an FDA 510(k) premarket notification submitted by Genosis, Inc. for the device "FERTELL FEMALE FERTILITY TEST". The FDA issued a decision of Substantially Equivalent on October 30, 2003. The device falls under product code NGA (Test, Follicle Stimulating Hormone (Fsh), Over The Counter), a Class I device regulated under 21 CFR 862.1300. Genosis, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2003
Date Received
June 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Device Class
Class I
Regulation Number
862.1300
Review Panel
TX
Submission Type

Other clearances by Genosis, Inc.

  • K041039 — FERTELL MALE FERTILITY TEST (July 20, 2004)

Other clearances for product code NGA

  • K070484 — QUANTRX FEMALE FERTILITY TEST (October 22, 2007)

FDA data resources