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510(k) K014123

BACTEC MGIT 960 SIRE KITS by Becton, Dickinson & CO — Product Code MJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
December 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Powders, Antimycobacterial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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Other clearances for product code MJA

  • K052323 — VERSATREK MYCO PZA KIT (January 19, 2006)
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  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
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