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510(k) K013874

Device
CLEARPLANE EASY OVULATION TEST
Applicant
UNIPATH LTD.
510(k) number
K013874
Product code
CEP  
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-19
Date received
2001-11-21
Regulation
862.1485
Classification name
Radioimmunoassay, Luteinizing Hormone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEVEN H ARMSTRONG
Address
390 Park Ave. New York NY US 10022 10022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?Mom2003-01-16
K022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.2002-11-05
K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.2002-05-24
K013323TCI-31 LIFELONG OVULATION TESTERTci New York2001-12-05
K012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.2001-08-24
K010244SURE CHECK OVULATION PREDICTORChembio Diagnostic Systems, Inc.2001-05-02
K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTSelfcare, Inc.2000-10-12
K991466EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)Selfcare, Inc.1999-05-25
K991386EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)Selfcare, Inc.1999-05-25
K990249OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031Phamatech1999-03-22
K983113BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KITSyntron Bioresearch, Inc.1998-11-18
K981271CLEARPLAN EASY OVULATION TESTUnipath , Ltd.1998-06-25
K974508DBEST ONE-STEP OVULATION TESTAmeritek, Inc.1998-02-02
K973310TBD* ONE-STEP OVULATION PREDICTOR TESTArmkel, LLC1997-10-27
K970467EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KITExcel Scientific, Inc.1997-03-18

Legacy Summary#

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FDA Review#

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