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510(k) K010537

LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC by Oxoid , Ltd. — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2001
Date Received
February 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

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  • K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M (December 10, 2001)
  • K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 22, 2000)
  • K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 15, 2000)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 2, 1999)

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