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Found 3 results
510(k) Data Aggregation
K Number
K980638Device Name
ADI SYPHILIS RPR LIQUID CONTROLS
Manufacturer
AMPCOR DIAGNOSTICS, INC.
Date Cleared
1998-07-06
(137 days)
Product Code
GMP
Regulation Number
866.3820Why did this record match?
Product Code :
GMP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.
Device Description
Not Found
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K Number
K961998Device Name
QUALITROL SYPHSERO CONTROL SET
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1996-08-08
(78 days)
Product Code
GMP
Regulation Number
866.3820Why did this record match?
Product Code :
GMP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955143Device Name
RPR LIQUID CONTROLS
Manufacturer
REMEL, L.P.
Date Cleared
1996-07-30
(260 days)
Product Code
GMP
Regulation Number
866.3820Why did this record match?
Product Code :
GMP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended use of the product
Device Description
Not Found
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