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510(k) K974883

BACTEC MGIT 960 SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
December 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • 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 MDB

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  • K190405 — BACT/ALERT MP Reagent System (May 15, 2019)
  • K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus (February 11, 2019)
  • K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a (March 16, 2018)
  • K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (March 28, 2017)
  • K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a P (February 9, 2017)
  • K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl (August 8, 2016)
  • K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic) (February 25, 2016)
  • K141810 — BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (December 10, 2014)