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510(k) K770655

LATELET DETERMIBATION KIT, UL 800 by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
April 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Platelet
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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  • 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)
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  • 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)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code GJP

  • K880608 — MSI-PC (March 21, 1988)
  • K823930 — HEMATOLOGY QUALITY CONTROL MIXTURE (February 1, 1983)
  • K771588 — PLATELET CONTROLS NORMAL & ABNORMAL (August 25, 1977)