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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, Micro, For Clinical Use
510(k) Number K943978
Device Name WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS
Applicant
Waters Chromatography Division
34 Maple St.
Milford,  MA  01757
Applicant Contact MARQUAND S RANSOM
Correspondent
Waters Chromatography Division
34 Maple St.
Milford,  MA  01757
Correspondent Contact MARQUAND S RANSOM
Regulation Number862.2170
Classification Product Code
JJF  
Date Received08/16/1994
Decision Date 05/02/1995
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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