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510(k) Data Aggregation
K Number
K021420Device Name
PARACON II/FECAL CONCENTRATOR II
Manufacturer
PARA SCIENTIFIC CO.
Date Cleared
2002-06-04
(32 days)
Product Code
LKS
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
PARA SCIENTIFIC CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from: fecal debris in preserved fecal specimens.
Fecal specimens that have been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be mated to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen.
The filtered specimen may then be concentrated by centrifugation, and observed microscopically.
Device Description
ParaCon II / Fecal Concentrator II is a filtration device.
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K Number
K964144Device Name
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
Manufacturer
PARA SCIENTIFIC CO.
Date Cleared
1996-11-27
(41 days)
Product Code
LIO
Regulation Number
866.2900Why did this record match?
Applicant Name (Manufacturer) :
PARA SCIENTIFIC CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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