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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K843395
Device Name ENCORE TSH REAGENT
Applicant
Hybritech, Inc.
11085 Torreyana Rd.
San Diego,  CA  92126
Applicant Contact JOHN F BRUNI
Correspondent
Hybritech, Inc.
11085 Torreyana Rd.
San Diego,  CA  92126
Correspondent Contact JOHN F BRUNI
Regulation Number862.1690
Classification Product Code
JLW  
Date Received08/29/1984
Decision Date 10/11/1984
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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