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FDA 510(k), K172787, Access hsTnl
FDA 510(k), K172787, Access hsTnl
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510(K) Number: K172787
Device Name: Access hsTnl
Manufacturer: Jennifer Lee Bennett
Device Classification Name: Immunoassay Method, Troponin Subunit
Regulation Number: MMI
Classification Product Code: 09/15/2017
Date Received: 06/14/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: Access hsTnl
Manufacturer: Jennifer Lee Bennett
Device Classification Name: Immunoassay Method, Troponin Subunit
Regulation Number: MMI
Classification Product Code: 09/15/2017
Date Received: 06/14/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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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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