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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 K974047
Device Name ACCUWELL PHENYLALANINE ASSAY
Applicant
Neometrics, Inc.
104bellerose Ave.
E. Northport,  NY  11731
Applicant Contact DAVID SCHWARTZ
Correspondent
Neometrics, Inc.
104bellerose Ave.
E. Northport,  NY  11731
Correspondent Contact DAVID SCHWARTZ
Regulation Number862.1555
Classification Product Code
JNB  
Date Received10/24/1997
Decision Date 12/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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