510(k) K771489

RTERIAL BLOOD SAMPLING KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GJE

K771489 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "RTERIAL BLOOD SAMPLING KIT". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1977
Date Received
August 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type