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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 K925093
Device Name SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
Applicant
Beckman Instruments, Inc.
1050 Page Mill Rd.
Bo 10200
Palo Alto,  CA  94303
Applicant Contact ROBERT H SLOCUM
Correspondent
Beckman Instruments, Inc.
1050 Page Mill Rd.
Bo 10200
Palo Alto,  CA  94303
Correspondent Contact ROBERT H SLOCUM
Regulation Number862.2170
Classification Product Code
JJF  
Date Received10/07/1992
Decision Date 11/16/1993
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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