510(k) K781330

BLOOD LEVEL DETECTOR-MODEL 7601 by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FJF

K781330 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BLOOD LEVEL DETECTOR-MODEL 7601". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code FJF (Detector, Air Bubble), a Class II device regulated under 21 CFR 876.5820. 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 31, 1978
Date Received
August 2, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Air Bubble
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type