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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 K950921
Device Name CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
Applicant
Nichols Institute Diagnostics
33608 Ortega Highway
San Juan Capistrano,  CA  92690 -6130
Applicant Contact DAVE D SMITH
Correspondent
Nichols Institute Diagnostics
33608 Ortega Highway
San Juan Capistrano,  CA  92690 -6130
Correspondent Contact DAVE D SMITH
Regulation Number862.1690
Classification Product Code
JLW  
Date Received03/01/1995
Decision Date 05/02/1995
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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