MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST


Device Classification Name

susceptibility test plate, antifungal

510(k) Number K991810
Device Name MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
29299 clemens rd., suite 1-k
westlake, 
OH 
44145

Applicant Contact cynthia c knapp
Correspondent
TREK DIAGNOSTIC SYSTEMS, INC.
29299 clemens rd., suite 1-k
westlake, 
OH 
44145

Correspodent Contact cynthia c knapp
Regulation Number 866.1640
Classification Product Code
NGZ  
Date Received 05/27/1999
Decision Date 10/09/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No