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510(k) K760942

GENTASAK by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1977
Date Received
November 1, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bacillus Subtilis, Microbiological Assay, Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
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)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code DKD

  • K780951 — BIO-MONITOR GENTAMICIN (August 14, 1978)