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510(k) K003062

BACTEC MGIT 960 SIR KITS by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code MJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
October 2, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Powders, Antimycobacterial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • 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)
  • K991551 — VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE (September 23, 1999)

Other clearances for product code MJA

  • K052323 — VERSATREK MYCO PZA KIT (January 19, 2006)
  • K021582 — BACTEC MGIT 960 PZA KIT (July 13, 2002)
  • K014123 — BACTEC MGIT 960 SIRE KITS (April 19, 2002)
  • K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (July 13, 1999)