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510(k) K962210

BACTEC 9050 SYSTEM by Becton Dickinson Diagnostic Instrument Systems — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
June 10, 1996
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 Diagnostic Instrument Systems

  • K954923 — BACTEC FUNGAL MEDIUM (November 21, 1996)
  • K954932 — BBL MGIT PRODUCTS (August 21, 1996)
  • K946268 — BACTEC(R) 9000TB SYSTEM (May 21, 1996)
  • K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) (May 17, 1996)
  • K954930 — BACTEC CULTURE VIALS, LYTIC, ANAEROBIC (February 16, 1996)
  • K954921 — BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS (February 16, 1996)
  • K954927 — BACTEC PEDS PLUS/F CULTURE VIALS (February 16, 1996)
  • K954925 — BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (February 16, 1996)
  • K954924 — BACTEC PEDS PLUS CLUTURE VIALS (February 8, 1996)
  • K955504 — QBC ACCUREAD SYSTEM (February 5, 1996)

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  • 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)