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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K870544
Device Name BIOMEK 1000 AUTOMATED LABORATORY WORK STATION
Applicant
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Applicant Contact JACK E SOROKIN
Correspondent
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Correspondent Contact JACK E SOROKIN
Regulation Number862.2750
Classification Product Code
JQW  
Date Received02/09/1987
Decision Date 04/22/1987
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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