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510(k) K983718

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
October 21, 1998
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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  • 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)

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