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510(k) K946268

BACTEC(R) 9000TB SYSTEM by Becton Dickinson Diagnostic Instrument Systems — Product Code MDB

K946268 is an FDA 510(k) premarket notification submitted by Becton Dickinson Diagnostic Instrument Systems for the device "BACTEC(R) 9000TB SYSTEM". The FDA issued a decision of Substantially Equivalent on May 21, 1996. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Becton Dickinson Diagnostic Instrument Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1996
Date Received
December 23, 1994
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)
  • K962210 — BACTEC 9050 SYSTEM (August 8, 1996)
  • K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) (May 17, 1996)
  • K954927 — BACTEC PEDS PLUS/F CULTURE VIALS (February 16, 1996)
  • K954921 — BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS (February 16, 1996)
  • K954930 — BACTEC CULTURE VIALS, LYTIC, ANAEROBIC (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)

Other clearances for product code MDB

  • K260213 — BD BACTEC FXI Culture System (May 28, 2026)
  • K222559 — BD BACTEC™ Myco/F Lytic Culture Vials (March 24, 2023)
  • K222591 — BD BACTEC™ Plus Aerobic/F 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)
  • 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)

FDA data resources