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FDA 510(k), K002177, THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
FDA 510(k), K002177, THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
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510(K) Number: K002177
Device Name: THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
Manufacturer: HAEMOSCOPE CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 07/19/2000
Decision Date: 09/14/2000
Regulation Medical Specialty: Hematology
Device Name: THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
Manufacturer: HAEMOSCOPE CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 07/19/2000
Decision Date: 09/14/2000
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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