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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K802574
Device Name BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
Applicant
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1050
Classification Product Code
CJE  
Date Received10/17/1980
Decision Date 11/12/1980
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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