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510(k) Data Aggregation
K Number
K041600Device Name
QWIKCHECK-BEADS
Manufacturer
MEDICAL ELECTRONICS SYSTEMS LTD.
Date Cleared
2004-07-27
(43 days)
Product Code
NRF, JJW
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONICS SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QwikCheck-beads™ is intended for in-vitro diagnostic use as sperm concentration quality control material for the SQA-V system (MES Ltd., Israel) in both the automated and manual visualization modes, as well as non-instrumented sperm cell counting chambers such as the hemacytometer (Neubauer type), and the non-dilutional chamber (Makler type).
Device Description
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