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510(k) K870999

Device
GENDER CHOICE INFORMATION KIT, FEMALE AND MALE
Applicant
PROCARE C/O WILEY, REIN & FIELDING
510(k) number
K870999
Product code
LHD  
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-14
Date received
1987-03-11
Regulation
510(k) Premarket Notification
Classification name
Device, Fertility Diagnostic, Proceptive
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Obstetrics/Gynecology
Device class
U
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANDREW S KRULWICH
Address
1776 K St. NW Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200163Ava Fertility TrackerAva AG2021-01-19
K122337OVUSENSEFertility Focus, Ltd.2013-08-06
K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.2011-12-20
K050094LADY COMP USALady Comp USA2006-04-20
K030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.2003-09-12
K021978PETIT SOPHIANishitomo Co., Inc.2003-04-08
K002726TCOYF FERTILITY SOFTWARE VERSION 1.0Ovusoft, LLC2001-04-06
K952756MEDI-AID BASAL THERMOMETERPolymedica Industries, Inc.1995-09-25
K945427B-D DIGITAL THERMOMETERBd Becton Dickinson Vacutainer Systems Preanalytic1995-06-15
K904211BIOSELF 2000 FERTILITY INDICATORBioself, Inc.1992-10-14
K901512L SOPHIANishitomo Co., Inc.1990-07-20
K880618FERTILITY FORECASTER COMPUTER PROGRAMFertile Time, Ltd.1988-06-24
K870528OVU-TRAC OVULATION TIMING KITOb/Gyn Concepts, Ltd.1987-05-06
K852194MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMETSharp Electronics Corp.1985-09-27
K852801BIOCHRON FERTILITY INDICATORFertil-A-Chron, Inc.1985-09-19

Legacy Summary#

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FDA Review#

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