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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Calcitonin
510(k) Number K945961
Device Name CALCITONIN IMMUNOASSAY 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 Number862.1140
Classification Product Code
JKR  
Date Received12/07/1994
Decision Date 11/20/1995
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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