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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 (Photometric, Discrete), For Clinical Use
510(k) Number K942922
Device Name SELECTA 20/60 CHEMISTRY ANALYZER
Applicant
Select Medical Systems, Inc.
4001 River View Dr.
Birmingham,  AL  35243
Applicant Contact SHERRY L MYERS
Correspondent
Select Medical Systems, Inc.
4001 River View Dr.
Birmingham,  AL  35243
Correspondent Contact SHERRY L MYERS
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CIX   CJE   JFJ   JHS  
Date Received06/21/1994
Decision Date 07/19/1995
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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