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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cyclic Amp
510(k) Number K823504
Device Name CYCLIC ADENOSINE MONOPHOSHATE BY RADIO
Applicant
Immuno Nuclear Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno Nuclear Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1230
Classification Product Code
CHO  
Date Received11/24/1982
Decision Date 01/28/1983
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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