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K Number
K954997

Validate with FDA (Live)

Device Name
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
Manufacturer
CENTOCOR, INC.
Date Cleared
1996-01-24

(84 days)

Product Code
JOZ
Regulation Number
864.5700
Type
Traditional
Panel
Hematology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K962426
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 864.5700 Automated platelet aggregation system.

(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).