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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 K941498
Device Name BIOMEK SL WITH BIOMEK SL INCUBATOR
Applicant
Beckman Analytical and Biotechnology Development
2500 Harbor Blvd.
Fullerton,  CA  92634
Applicant Contact F. DAVID KALFELL
Correspondent
Beckman Analytical and Biotechnology Development
2500 Harbor Blvd.
Fullerton,  CA  92634
Correspondent Contact F. DAVID KALFELL
Regulation Number862.2750
Classification Product Code
JQW  
Date Received03/28/1994
Decision Date 07/14/1994
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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