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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 K833471
Device Name ADRENOCOR TICOTROPIC HORMONE RADIOIMM
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NICHOLS INSTITUTE DIAGNOSTICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1025
Classification Product Code
CKG  
Date Received10/06/1983
Decision Date 01/11/1984
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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