SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS— 510(k) K081063

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K081063 for SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS, Substantially Equivalent on 2009-03-06. Applicant: Trek Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant
Trek Diagnostic Systems, Inc.
Product code
Code NGZ
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cleveland, OH, US
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