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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Centrifugal, For Clinical Use
510(k) Number K903626
Device Name BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
Applicant
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Applicant Contact WILLIAM W DAVIS
Correspondent
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Correspondent Contact WILLIAM W DAVIS
Regulation Number862.2140
Classification Product Code
JJG  
Date Received08/10/1990
Decision Date 10/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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