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510(k) K850579

Device
CUE FERTILITY MONITOR
Applicant
ZETEK, INC.
510(k) number
K850579
Product code
NGE  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-22
Date received
1985-02-13
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
Third party reviewed
No

Applicant Contact#

Contact
Joseph R RADZIUS
Address
Burditt, Bowles & Radzius, Ltd 135 S. La Salle St. Chicago IL US 60603 60603

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
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

Legacy Summary#

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FDA Review#

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