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FDA 510(k) K041502, THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY, by Haemoscope Corp.

FDA 510(k) K041502, THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY, by Haemoscope Corp.

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510(K) Number: K041502
Device Name: THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
Manufacturer: Haemoscope Corp.
Device Classification Name: system, automated platelet aggregation
Regulation Number: 864.5700
Classification Product Code: JOZ
Date Received: 06/07/2004
Decision Date: 09/01/2004
Regulation Medical Specialty: Hematology
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