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510(k) Data Aggregation
K Number
K962664Device Name
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
Manufacturer
Date Cleared
1996-09-10
(63 days)
Product Code
Regulation Number
864.5400Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin III.
Device Description
A detailed description of the device, including an explanation of how it functions and the basic scientific concepts, are described in the ELECTRA 1800C Operator's Manual, Chaper 1 - Getting Started ..
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