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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 K943547
Device Name PHENYLALANINE TEST KIT
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact JANET D PERKINS
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact JANET D PERKINS
Regulation Number862.1555
Classification Product Code
JNB  
Subsequent Product Code
JJX  
Date Received07/21/1994
Decision Date 01/26/1996
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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