510(k) K771523

LATELET RETENTION COLUMN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JBZ

K771523 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "LATELET RETENTION COLUMN". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code JBZ (Study, Platelet Adhesive), a Class II device regulated under 21 CFR 864.6650. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
August 8, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Study, Platelet Adhesive
Device Class
Class II
Regulation Number
864.6650
Review Panel
HE
Submission Type