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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 K811565
Device Name ACTH RADIOIMMUNOASSAY KIT
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 Number862.1025
Classification Product Code
CKG  
Date Received06/04/1981
Decision Date 06/25/1981
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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