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510(k) K260128

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes by Becton, Dickinson and Company — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
January 16, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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Other clearances for product code JKA

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