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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
510(k) Number K891070
Device Name PHENYLALANINE (NINHYDRIN REACTION)
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 Number862.1555
Classification Product Code
JNB  
Date Received03/01/1989
Decision Date 10/27/1989
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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