QUANTRX FEMALE FERTILITY TEST— 510(k) K070484

Name: FDA 510(k) clearance K070484
Creator: U.S. Food and Drug Administration
Published: 2007-10-22

Substantially Equivalent

Quantrx Biomedical Corporation

FDA 510(k) clearance K070484 for QUANTRX FEMALE FERTILITY TEST, Substantially Equivalent on 2007-10-22. Applicant: Quantrx Biomedical Corporation. Device class: 1.

Clearance details

Applicant: Quantrx Biomedical Corporation
Product code: Code NGA
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 2007-02-20
Decision date: 2007-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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