QWIKCHECK-BEADS

Material, Quality Control, Semen Analysis

MEDICAL ELECTRONICS SYSTEMS LTD.

The following data is part of a premarket notification filed by Medical Electronics Systems Ltd. with the FDA for Qwikcheck-beads.

Pre-market Notification Details

Device IDK041600
510k NumberK041600
Device Name:QWIKCHECK-BEADS
ClassificationMaterial, Quality Control, Semen Analysis
Applicant MEDICAL ELECTRONICS SYSTEMS LTD. 575 Shirlynn Court Los Altos,  CA  94022
ContactErika B Ammirati
CorrespondentErika B Ammirati
MEDICAL ELECTRONICS SYSTEMS LTD. 575 Shirlynn Court Los Altos,  CA  94022
Product CodeNRF  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-14
Decision Date2004-07-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016650020 K041600 000
07290012140600 K041600 000
07290012140136 K041600 000

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