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510(k) Data Aggregation
K Number
K983310Device Name
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
Manufacturer
ACCUMED INTL., INC.
Date Cleared
1998-12-17
(87 days)
Product Code
JTT, JWY, LTT
Regulation Number
866.1640Why did this record match?
Product Code :
JTT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. Organisms indicated for testing in the approved FDA Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.
Device Description
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