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510(k) K070484

QUANTRX FEMALE FERTILITY TEST by Quantrx Biomedical Corporation — Product Code NGA

K070484 is an FDA 510(k) premarket notification submitted by Quantrx Biomedical Corporation for the device "QUANTRX FEMALE FERTILITY TEST". The FDA issued a decision of Substantially Equivalent on October 22, 2007. 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. Quantrx Biomedical Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2007
Date Received
February 20, 2007
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 Quantrx Biomedical Corporation

  • K080436 — RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 (February 11, 2009)
  • K080431 — RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 (January 8, 2009)
  • K080455 — RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 (December 31, 2008)

Other clearances for product code NGA

  • K032002 — FERTELL FEMALE FERTILITY TEST (October 30, 2003)

FDA data resources