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510(k) K161810

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial by Becton Dickinson — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2017
Date Received
July 1, 2016
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 Becton Dickinson

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  • K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl (August 8, 2016)
  • K113241 — BD EMERALD SINGLE USE, HYPODERMIC SYRINGE (November 28, 2011)
  • K041478 — BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR (October 28, 2004)
  • K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE (August 26, 2004)

Other clearances for product code MDB

  • K222591 — BD BACTEC™ Plus Aerobic/F Culture Vials (March 24, 2023)
  • K222559 — BD BACTEC™ Myco/F Lytic Culture Vials (March 24, 2023)
  • 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)
  • 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)
  • K123903 — BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (May 13, 2013)