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510(k) K923892

SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA by Smith River Biologicals — Product Code JSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1993
Date Received
August 4, 1992
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 Smith River Biologicals

  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (April 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (April 17, 1984)
  • K841206 — NON-SELECTIVE & DIFFERENTIAL (April 17, 1984)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (April 17, 1984)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K841211 — SELECTIVE BROTH (April 5, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (April 4, 1984)
  • K841203 — GENERAL NUTRIENT BROTH (April 4, 1984)
  • K841213 — ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (April 4, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (April 4, 1984)

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)