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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 K844135
Device Name PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU
Applicant
Immuno Nuclear Corp.
1951 Northwestern Ave.
P.O. Bo 285
Stillwater,  MN  55082
Applicant Contact LISA J ANDERSEN
Correspondent
Immuno Nuclear Corp.
1951 Northwestern Ave.
P.O. Bo 285
Stillwater,  MN  55082
Correspondent Contact LISA J ANDERSEN
Regulation Number862.1230
Classification Product Code
CHO  
Date Received10/23/1984
Decision Date 03/05/1985
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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