510(k) K230493

BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube by Becton, Dickinson and Company — Product Code GIM

K230493 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube". The FDA issued a decision of Substantially Equivalent on November 27, 2023. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2023
Date Received
February 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type