510(k) K992849

QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GKZ

K992849 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 1999. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1999
Date Received
August 24, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type