FDA 510(k) Application Details - K220212

Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection

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510(K) Number K220212
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact Kelly Hilliger
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Regulation Number 862.1675

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Classification Product Code JKA
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Date Received 01/26/2022
Decision Date 03/24/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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