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510(k) K790899

BACTEC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
May 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amikacin Serum Assay
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

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  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
  • 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 KLP

  • K032279 — ONLINE TDM AMIKA (October 10, 2003)
  • K873426 — EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 (October 29, 1987)
  • K780949 — BIO-MONITOR AMIKACIN (August 14, 1978)