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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Immunoreactive Insulin
510(k) Number K841573
Device Name INSULIN RADIOIMMUNOASSAY KIT
Applicant
Sorin Biomedica, Fiat, USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1405
Classification Product Code
CFP  
Date Received04/17/1984
Decision Date 05/16/1984
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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