FDA.reportPublic FDA data

510(k) K020808

Device
FERTILITE OV
Applicant
PHEROMONE SCIENCES CORP.
510(k) number
K020808
Product code
NGE  
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-23
Date received
2002-03-12
Regulation
862.1485
Classification name
Test, Luteinizing Hormone (lh), Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY T SOLATE
Address
443 King St. E. 2nd Floor Toronto CA M5A 1L5 M5A 1L5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990223MODIFICATION OF CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.1999-02-24
K981207CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.1998-10-28
K973860OVULON MONITORConception Technology, Inc.1998-01-07
K863121PEAK OVULATION PREDICTORMicron Technology, Inc.1986-10-14
K850579CUE FERTILITY MONITORZetek, Inc.1985-03-22

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases