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FDA 510(k), K193041, Hemochron Signature Elite
FDA 510(k), K193041, Hemochron Signature Elite
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$149.00 USD
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510(K) Number: K193041
Device Name: Hemochron Signature Elite
Manufacturer: Accriva Diagnostics, Inc.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 10/31/2019
Decision Date: 11/22/2019
Regulation Medical Specialty: Hematology
Device Name: Hemochron Signature Elite
Manufacturer: Accriva Diagnostics, Inc.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 10/31/2019
Decision Date: 11/22/2019
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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