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FDA 510(k), K230391, BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
FDA 510(k), K230391, BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
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510(K) Number: K230391
Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
Manufacturer: Katherine Kenner Lemus
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 02/14/2023
Date Received: 12/01/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
Manufacturer: Katherine Kenner Lemus
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 02/14/2023
Date Received: 12/01/2023
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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