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510(k) K041600

Device
QWIKCHECK-BEADS
Applicant
MEDICAL ELECTRONICS SYSTEMS LTD.
510(k) number
K041600
Product code
NRF  
Decision
Substantially Equivalent (SESE)
Decision date
2004-07-27
Date received
2004-06-14
Regulation
864.8625
Classification name
Material, Quality Control, Semen Analysis
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Erika B Ammirati
Address
575 Shirlynn Ct. Los Angeles CA US 94022 94022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NRF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042750QC-BEADSBioscreen, Inc.2004-10-29
K041240SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYEDFertility Solutions, Inc.2004-06-02

Legacy Summary#

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FDA Review#

Decision Summary