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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 K921816
Device Name VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
Applicant
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact VICKI ANASTASI
Correspondent
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact VICKI ANASTASI
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/15/1992
Decision Date 06/18/1992
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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