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510(k) Data Aggregation
K Number
K970100Device Name
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
Manufacturer
SIMPLICITY DIAGNOSTICS, INC.
Date Cleared
1997-03-10
(59 days)
Product Code
MJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
SIMPLICITY DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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