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510(k) K181092

CHROMID CARBA agar (CARB) by Biomerieux S.A. — Product Code JSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2018
Date Received
April 25, 2018
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)
  • 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)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)