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FDA 510(k), K073377, ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k), K073377, ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
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510(K) Number: K073377
Device Name: ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
Manufacturer: INSTRUMENTATION LABORATORY CO.
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 12/03/2007
Decision Date: 05/04/2008
Regulation Medical Specialty: Hematology
Device Name: ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
Manufacturer: INSTRUMENTATION LABORATORY CO.
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 12/03/2007
Decision Date: 05/04/2008
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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