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510(k) K024353

Device
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
510(k) number
K024353
Product code
LTT  
Decision
Substantially Equivalent (SESE)
Decision date
2003-03-06
Date received
2002-12-30
Regulation
866.1640
Classification name
Panels, Test, Susceptibility, Antimicrobial
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CYNTHIA C KNAPP
Address
982 Keynote Cir., Suite 6 Cleveland OH US 44131 44131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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