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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Yeast
510(k) Number K993554
Device Name YEASTEST
Applicant
Diagnostic Markers, Inc.
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Diagnostic Markers, Inc.
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number866.2660
Classification Product Code
JXB  
Date Received10/20/1999
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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