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510(k) K992849

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

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

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  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K991551 — VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE (September 23, 1999)

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