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FDA 510(k), K150877, ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k), K150877, ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
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510(K) Number: K150877
Device Name: ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
Manufacturer: Instrumentation Laboratory Co.
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 04/01/2015
Decision Date: 12/13/2015
Regulation Medical Specialty: Hematology
Device Name: ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
Manufacturer: Instrumentation Laboratory Co.
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 04/01/2015
Decision Date: 12/13/2015
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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