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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 K961650
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT
Applicant
Nichols Institute Diagnostics
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact DAVE D SMITH
Correspondent
Nichols Institute Diagnostics
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact DAVE D SMITH
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JIS  
Date Received04/30/1996
Decision Date 07/16/1996
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
Recalls CDRH Recalls
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