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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 K853717
Device Name ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
Applicant
Nichols Institute Diagnostics
26441 Via De Anza
San Juan Capistrano,  CA  92675
Applicant Contact ELAINE WALTON
Correspondent
Nichols Institute Diagnostics
26441 Via De Anza
San Juan Capistrano,  CA  92675
Correspondent Contact ELAINE WALTON
Regulation Number862.1690
Classification Product Code
JLW  
Date Received09/05/1985
Decision Date 10/02/1985
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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