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510(k) K222559

BD BACTEC™ Myco/F Lytic Culture Vials by Becton, Dickinson and Company — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2023
Date Received
August 24, 2022
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

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  • K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (March 28, 2017)
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  • 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)
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