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510(k) Data Aggregation
K Number
K014028Device Name
CARESIDE APTT
Manufacturer
CARESIDE HEMOTOLOGY, INC.
Date Cleared
2002-02-08
(64 days)
Product Code
GFO, 81G
Regulation Number
864.7925Why did this record match?
Applicant Name (Manufacturer) :
CARESIDE HEMOTOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or citrated plasma as an aid in the diagnosis of patients with clotting disorders and to monitor patients receiving heparin anticoagulation therapy.
Device Description
CARESIDE APTT cartridges are used with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or plasma as the applied sample. The CARESIDE APTT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma to a cartridge cuvette to initiate the measurement of an activated partial thromboplastin time. The patented cartridge contains all reagents necessary to measure an activated partial thromboplastin time.
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