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510(k) K070361

MRSASELECT by Bio-Rad — Product Code JSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2007
Date Received
February 7, 2007
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

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)
  • K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (November 9, 2005)

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)