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510(k) Data Aggregation
K Number
K962499Device Name
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
Manufacturer
Date Cleared
1996-09-05
(71 days)
Product Code
Regulation Number
866.4520Why did this record match?
Product Code :
JZT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
In combination with approved microplate tests (such as the Bartels manufactured, Zymmune™ CD4/CD8 Cell monitoring assay kit) the Zymmune™ Auto-Reader F [with software] is intended for use for in vitro quantification and monitoring of T-cell levels.
Device Description
The Zymmune™ Auto-Reader F is a microplate reader that measures relative fluorescence signals from samples in a 96-well microplate. The Auto-Reader F is designed to be used with integrated software which collects and reports the measurements made by the microplate reader.
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