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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(k) Number K950524
Device Name NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
Applicant
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact DAVE D SMITH
Correspondent
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact DAVE D SMITH
Regulation Number862.1245
Classification Product Code
JKC  
Date Received01/30/1995
Decision Date 05/15/1995
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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