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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Selective And Non-Differential
510(k) Number K875273
Device Name BITEK(TM) BLOOD CULTURE SYSTEM
Applicant
Definitive Diagnostics, Inc.
P.O. Box 578
Tualatin,  OR  97062
Applicant Contact GARY WICKLUND
Correspondent
Definitive Diagnostics, Inc.
P.O. Box 578
Tualatin,  OR  97062
Correspondent Contact GARY WICKLUND
Regulation Number866.2300
Classification Product Code
JSG  
Date Received12/24/1987
Decision Date 01/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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