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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K972974
Device Name ACCUWELL T4-EIA
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 Number862.1700
Classification Product Code
KLI  
Date Received08/11/1997
Decision Date 10/06/1997
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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