510(k) K982922

VACUTAINER BRAND BLOOD COLLECTION SYRINGE by Becton Dickinson Vacutainer Systems — Product Code JKA

K982922 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "VACUTAINER BRAND BLOOD COLLECTION SYRINGE". The FDA issued a decision of Substantially Equivalent on September 22, 1998. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
August 19, 1998
Clearance Type
Traditional
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