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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Methods, Galactose
510(k) Number K991498
Device Name ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
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 Number862.1310
Classification Product Code
JIA  
Date Received04/29/1999
Decision Date 06/16/1999
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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