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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 K851542
Device Name RFA-300 RAPID FLOW ANALYZER W/COMPUTER
Applicant
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Applicant Contact OR WI
Correspondent
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Correspondent Contact OR WI
Regulation Number862.2170
Classification Product Code
JJF  
Date Received04/16/1985
Decision Date 05/10/1985
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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