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K Number
K010158
Device Name
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-03-22

(64 days)

Product Code
GGO
Regulation Number
864.7925
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).