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FDA 510(k), K220677, Kurin Blood Culture Collection Set with Kurin Lock Technology
FDA 510(k), K220677, Kurin Blood Culture Collection Set with Kurin Lock Technology
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510(K) Number: K220677
Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology
Manufacturer: Neal Hartman
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: KXA
Date Received: 03/08/2022
Decision Date: 04/28/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology
Manufacturer: Neal Hartman
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: KXA
Date Received: 03/08/2022
Decision Date: 04/28/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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