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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 K903391
Device Name ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM
Applicant
Nichols Institute
Worldway Postal Center
P.O. Box 92797
Los Angeles,  CA  90009
Applicant Contact ELAINE WALTON
Correspondent
Nichols Institute
Worldway Postal Center
P.O. Box 92797
Los Angeles,  CA  90009
Correspondent Contact ELAINE WALTON
Regulation Number862.1690
Classification Product Code
JLW  
Date Received07/27/1990
Decision Date 10/12/1990
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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