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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 (Sequential Multiple, Continuous Flow) Clinical Use
510(k) Number K852306
Device Name REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
Applicant
Methodist Hospital of Memphis
1265 Union Ave.
Memphis,  TN  38104
Applicant Contact VON BOECKMAN
Correspondent
Methodist Hospital of Memphis
1265 Union Ave.
Memphis,  TN  38104
Correspondent Contact VON BOECKMAN
Regulation Number862.2150
Classification Product Code
JJC  
Date Received05/29/1985
Decision Date 08/02/1985
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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