510(k) K813033

CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GKG

K813033 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
October 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuge, Hematocrit
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type