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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 K851638
Device Name CLINALYZER MODEL VX-1000
Applicant
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Applicant Contact WILLIAM H SOUDER
Correspondent
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Correspondent Contact WILLIAM H SOUDER
Regulation Number862.2160
Classification Product Code
JJE  
Date Received04/19/1985
Decision Date 05/13/1985
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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