QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS

Semen Analysis Device

MEDICAL ELECTRONIC SYSTEMS LTD.

The following data is part of a premarket notification filed by Medical Electronic Systems Ltd. with the FDA for Qwikcheck Test Strips- Reagent Strips For Semen Analysis.

Pre-market Notification Details

Device IDK063864
510k NumberK063864
Device Name:QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
ClassificationSemen Analysis Device
Applicant MEDICAL ELECTRONIC SYSTEMS LTD. 575 SHIRLYNN CT. Los Altos,  CA  94022
ContactErika B Ammirati
CorrespondentErika B Ammirati
MEDICAL ELECTRONIC SYSTEMS LTD. 575 SHIRLYNN CT. Los Altos,  CA  94022
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-29
Decision Date2007-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290012140167 K063864 000

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