MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST— 510(k) K991810

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K991810 for MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST, Substantially Equivalent on 2001-10-09. Applicant: Trek Diagnostic Systems, Inc..

Clearance details

Applicant: Trek Diagnostic Systems, Inc.
Product code: Code NGZ
Advisory panel: Microbiology
Date received: 1999-05-27
Decision date: 2001-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

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