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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 K841478
Device Name RIANEN CYCLIC-AMP RADIOIMMUNOASSAY
Applicant
New England Nuclear
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
New England Nuclear
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1230
Classification Product Code
CHO  
Date Received04/09/1984
Decision Date 06/14/1984
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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