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FDA 510(k), K162233, Kurin Blood Culture Collection Set
FDA 510(k), K162233, Kurin Blood Culture Collection Set
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510(K) Number: K162233
Device Name: Kurin Blood Culture Collection Set
Manufacturer: Emily Davis
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: KXA
Date Received: 08/08/2016
Decision Date: 12/23/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: Kurin Blood Culture Collection Set
Manufacturer: Emily Davis
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: KXA
Date Received: 08/08/2016
Decision Date: 12/23/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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