SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES— 510(k) K053243

Name: FDA 510(k) clearance K053243
Creator: U.S. Food and Drug Administration
Published: 2006-01-20

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K053243 for SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES, Substantially Equivalent on 2006-01-20. Applicant: Trek Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Trek Diagnostic Systems, Inc.
Product code: Code LRG
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2005-11-21
Decision date: 2006-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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