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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 K882741
Device Name ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
Applicant
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Applicant Contact ELAINE WALTON
Correspondent
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Correspondent Contact ELAINE WALTON
Regulation Number862.1025
Classification Product Code
CKG  
Date Received07/01/1988
Decision Date 08/30/1988
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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