Bactec(R) 9000TB System

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K946268 ↗

FDA Product Code

MDB

Device Class

Class I

Regulation

21 CFR Part 866.2560

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Qbc Accuread System

  Class II

  FDA 510(k) K955504 Active Cleared 5 Feb 1996

• Bactec Lytic/10 Anaerobic/F Culture Vials

  Class I

  FDA 510(k) K954925 Active Cleared 16 Feb 1996

• Bactec Standard/10 Aerobic/F Culture Vials

  Class I

  FDA 510(k) K954921 Active Cleared 16 Feb 1996

• Qbc Accutube

  Class II

  FDA 510(k) K945205 Active Cleared 25 Sep 1995

• Bactec Peds Plus Cluture Vials

  Class I

  FDA 510(k) K954924 Active Cleared 8 Feb 1996

• Qbc Accutube(423406)/Qbc Autoread(424571)

  Class II

  FDA 510(k) K960827 Active Cleared 17 May 1996

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