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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K851079
Device Name BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
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 Number862.1660
Classification Product Code
JJX  
Date Received03/18/1985
Decision Date 04/10/1985
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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