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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K931777
Device Name APO A-1 CHEMILUMINESCENCE ASSAY
Applicant
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact RAMAKRISHNAN
Correspondent
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact RAMAKRISHNAN
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received04/09/1993
Decision Date 08/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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