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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Acth
510(k) Number K850882
Device Name ACTH II BY RADIOIMMUNOASSAY
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 Number862.1025
Classification Product Code
CKG  
Date Received03/04/1985
Decision Date 03/21/1985
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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