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510(k) K190405

BACT/ALERT MP Reagent System by bioMerieux, Inc. — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2019
Date Received
February 19, 2019
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

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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)
  • 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)
  • K123903 — BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (May 13, 2013)