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510(k) K990223

Device
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
Applicant
UNIPATH LTD.
510(k) number
K990223
Product code
NGE  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-24
Date received
1999-01-25
Regulation
862.1485
Classification name
Test, Luteinizing Hormone (lh), Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Louise Roberts
Address
Priory Business Park Bedford GB MK44 3UP MK44 3UP

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020808FERTILITE OVPheromone Sciences Corp.2002-09-23
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#

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FDA Review#

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