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510(k) K042812

BBLCHROMAGAR MRSA by Becton, Dickinson & CO — Product Code JSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2004
Date Received
October 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

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Other clearances for product code JSO

  • K190553 — HardyCHROM CRE (April 29, 2019)
  • K181092 — CHROMID CARBA agar (CARB) (July 6, 2018)
  • K171061 — MRSASelect II (December 28, 2017)
  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K160512 — HardyCHROM ESBL (November 15, 2016)
  • K162076 — chromID MRSA (October 25, 2016)
  • K151688 — chromID MRSA (March 11, 2016)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K102922 — HARDYCHROM MRSA (May 4, 2011)