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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K901939
Device Name NEOCOAT T4
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
CDX  
Date Received04/30/1990
Decision Date 05/31/1990
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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