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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
510(k) Number K894011
Device Name TOTAL GALACTOSE
Applicant
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Applicant Contact RAYMOND L PAVITT
Correspondent
Alpkem Corp.
Box 1260
Clackamas,  OR  97015
Correspondent Contact RAYMOND L PAVITT
Regulation Number862.1315
Classification Product Code
KQP  
Date Received06/06/1989
Decision Date 01/11/1990
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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