Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FERTELL FEMALE FERTILITY TEST

K-Number: K032002 · 2003-10-30

ApplicantGenosis, Inc.
Decision Date2003-10-30
Product CodeNGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERTELL FEMALE FERTILITY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genosis, Inc.. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K032002. The device is classified under product code NGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERTELL FEMALE FERTILITY TEST?

FERTELL FEMALE FERTILITY TEST is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Genosis, Inc.. The 510(k) number is K032002.

When did FERTELL FEMALE FERTILITY TEST receive FDA 510(k) clearance?

FERTELL FEMALE FERTILITY TEST received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032002.

Who is the listed applicant for FERTELL FEMALE FERTILITY TEST?

The FDA 510(k) record lists Genosis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FERTELL FEMALE FERTILITY TEST?

The FDA product code for FERTELL FEMALE FERTILITY TEST is NGA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: NGA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070484QUANTRX FEMALE FERTILITY TESTQuantrx Biomedical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑